MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-08 for PRELUDE SHEATH INTRODUCER PSI-6F-11-018/CN manufactured by Merit Medical Systems Inc..
[183020439]
The suspect device was not returned for evaluation. The complaint could not be confirmed. The root cause could not be determined. A search of the complaint database was performed and no similar complaints for this lot number were found. The device history record was reviewed and no exception documents were found.
Patient Sequence No: 1, Text Type: N, H10
[186549235]
The suspect device is not expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[186549236]
The account alleges that during a percutaneous transluminal angioplasty procedure, the access guidewire detached. The physician was attempting to acquire retrograde radial artery access and after removing the vascular access wire along with the sheath introducer, the physician noticed that the tip was missing. An x-ray revealed that the guidewire tip had detached within the patient's subcutaneous tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2020-00002 |
| MDR Report Key | 9566268 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-09 |
| Date of Event | 2019-11-28 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2018-08-28 |
| Date Added to Maude | 2020-01-08 |
| 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. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRELUDE SHEATH INTRODUCER |
| Generic Name | SHEATH INTRODUCER |
| Product Code | DRE |
| Date Received | 2020-01-08 |
| Catalog Number | PSI-6F-11-018/CN |
| Lot Number | H1409902 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Address | 1600 MERIT PARKWAY SOUTH JORDAN, UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |