MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-03-01 for SPECTRANETICS BRIDGE BALLOON PREP KIT K12-09098A manufactured by Merit Medical Systems Inc.
[101299979]
The suspect device is not expected to return for evaluation. A review of the device history and complaint database could not be performed since the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
[101299980]
On (b)(6) 2017 the patient presented with an unexplained chronic fever. The patient had previous documentation of a pulmonary embolism [pe] with moderate pulmonary hypertension via a nuclear scan. A tee revealed vegetation. Physician thinks that the pe is likely related to a septic embolus. On (b)(6) 2017 -the physician alleges that during a transvenous lead extraction a balloon wire was placed prophylactically for possible svc perforation during the lead extraction procedure. The physician reported that the balloon was inflated (non-emergently) and deflated within the patients svc, then pulled back into the ivc for the remainder of the procedure. The patient developed thrombus. An intraoperative tee was ordered. The physician noted an echogenic mass as the procedure progressed, this mass rapidly became larger with echogenicity [suspicious of thrombus]. The patient was tested for hypercoagulable status which was negative. She was treated for 3 months with anticoagulants. The physician was concerned that the prophylactic placement could potentially have caused thrombogenicity. Patient-related outcomes post-procedure are unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2018-00022 |
| MDR Report Key | 7306780 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-03-01 |
| Date of Report | 2018-02-20 |
| Date of Event | 2017-10-31 |
| Date Mfgr Received | 2018-02-20 |
| Date Added to Maude | 2018-03-01 |
| 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. CASEY HUGHES MS, CQE, CSQP |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8013164932 |
| 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 | SPECTRANETICS BRIDGE BALLOON PREP KIT |
| Generic Name | BALLOON PREP KIT |
| Product Code | OJV |
| Date Received | 2018-03-01 |
| Catalog Number | K12-09098A |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 1. Life Threatening; 2. Required No Informationntervention | 2018-03-01 |