MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-28 for SINGLE LUMEN EMBOLECTOMY CATHETER 1601-48 manufactured by Lemaitre Vascular, Inc..
[188405342]
We have received the catheter as well as the dislodged catheter tip for evaluation. The catheter broke just below the proximal ligature. The distal end of the catheter shaft where it separated was observed to have stretched extensively. The last 8 cm stretched to 18 cm ( 44% elongation). As a result, the inflation hole was completely occluded. The proximal ligature was partially undone but did not show any sign of slippage. The distal ligature remained intact and properly secured to the shaft of the catheter. During our follow-up conversation with the contact person at the hospital, we learned that the malfunction occurred during the second pass. Surgeon was unable to deflate the balloon when he attempted to remove the catheter from the patient's vessel. The contact person also stated that the pictures from the angiogram taken prior to the surgery did not show extensive calcification or stenosis in the patient's artery. She could not confirm if the catheter was used to remove a fresh clot or an adherent mature clot. Based on our device evaluation, it is likely that some procedural factors ( use of excessive force to remove the clot) may have contributed to this malfunction. The necking of the catheter shaft that we observed in this catheter likely resulted due to excessive force that was exerted when removing the clot which blocked the inflation lumen and prevented the balloon from deflating. As surgeon exerted additional force to remove this undeflated balloon from the vessel, it likely resulted in the tip separation. Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident. Further, we have not received any other complaints of a similar nature for devices from this lot. As part of our manufacturing process, a 100% balloon and winding inspection are performed on each of the manufactured product to ensure each catheter operates properly. We have performed a pull test on a sample of units from this lot number during our in-process inspection. All of those units passed the test requirements when the balloons were pull tested to their validated force. Our ifu appropriately warns the users about the risks that could occur with the use of the embolectomy catheter including the risk of tip separation. The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material ( eg. Chronic clot, atherosclerotic plaque ). This catheter is not designed to withstand the additional pull force needed to remove these materials. As of the latest information received on 30/01/2020, patient was still at hospital, but doing well with no signs of complication from the malfunction.
Patient Sequence No: 1, Text Type: N, H10
[188405343]
During thrombectomy in superficial femoral artery, catheter tip dislodged from the catheter shaft during removal of residual thrombi from the patient's vessel. The malfunction occurred during second pass. Surgeon was able to remove the catheter tip from the patient's vessel. The malfunction extended operating time period but did not result in any patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2020-00024 |
| MDR Report Key | 9770750 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2018-11-29 |
| Date Added to Maude | 2020-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PRAGYA THIKEY |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 2212266152 |
| Manufacturer G1 | LEMAITRE VASCULAR, INC. |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE LUMEN EMBOLECTOMY CATHETER |
| Generic Name | EMBOLECTOMY CATHETER |
| Product Code | DXE |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-02-14 |
| Model Number | 1601-48 |
| Catalog Number | 1601-48 |
| Lot Number | SLC4825 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention; 3. Deathisabilit | 2020-02-28 |