MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-13 for HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL 82-3072 manufactured by Codman & Shurtleff, Inc. Medos S.a..
[1995568]
Medwatch explains that pt is a toddler. Shunt was placed approx 2. 5 yrs ago for hydrocephalus. Pt was noted to have pooling of subcutaneous fluid around the shunt components. A shunt survey was done and showed a disconnection just at the bottom side of her valve. Csf was found to be freely coming from the distal valve. The original connection of the distal catheter to the valve was still intact with the suture in place, but the catheter had ruptured just 0. 5 cm below this. A new bactiseal peritoneal tubing was pulled into place. The old peritoneal catheter was then removed and was sent for pathologic eval.
Patient Sequence No: 1, Text Type: D, B5
[9148890]
Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[9393601]
Device evaluation: it was discovered that this complaint has been reported twice. As a result (b)(4) is being closed. Please also refer to complaint (b)(4) for the complaint evaluation. Upon completion of the investigation it was noted that one end of the catheter had a clean cut and the other end was slightly jagged. It was also noted that during irrigation of the device an occlusion was found along with clear biological particles that was flushed from the catheter. It appears the problem reported by the customer was caused from the occlusion that was noted. It is not clear how the rupture of the catheter happened. It is indicated in the instructions for use that extreme care should be used when handling silicone products as silicone has a low tear resistance. A review of the device history records confirmed that the device conformed to the required specifications when released to stock. Based on the results of this investigation, no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
[9434535]
A follow up report is being filed in an attempt to clarify the investigation results. Upon completion of the investigation it was noted that one end of the catheter had a clean cut and the other end was slightly jagged. It was also noted that during irrigation of the device an occlusion was found along with clear biological particles that was flushed from the catheter. The root cause of the subcutaneous accumulation of fluid reported by the customer appears to have been caused by that of a rupture in the catheter. The root cause of the rupture of the catheter was not clearly determined however as noted in the ifu, silicone has a low cut and tears resistance and must be handled with care. A review of the device history records confirmed that the device conformed to the required specifications when released to stock. Based on the results of this investigation, no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2011-00268 |
| MDR Report Key | 2194686 |
| Report Source | 06 |
| Date Received | 2011-07-13 |
| Date of Event | 2011-05-27 |
| Date Reported to Mfgr | 2011-06-21 |
| Date Mfgr Received | 2011-06-21 |
| Device Manufacturer Date | 2011-07-17 |
| Date Added to Maude | 2011-08-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. MEDOS S.A. |
| Manufacturer Street | RUE GIRARDET 29 |
| Manufacturer City | LE LOCLE CH-2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-2400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL |
| Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS |
| Product Code | HCA |
| Date Received | 2011-07-13 |
| Model Number | NA |
| Catalog Number | 82-3072 |
| Lot Number | CJCBK6 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. MEDOS S.A. |
| Manufacturer Address | RUE GIRARDET 29 LE LOCLE CH-2400 SZ CH-2400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-13 |