MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET FFR WIRE; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number 0.014/185CM

Device Problems Fracture (1260); Sticking (1597); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/26/2016

Event Type  malfunction  

Event Description

Pci procedure: right radial artery was entered percutaneously with a modified seldinger technique.A 6 fr mid-sized sheath was advanced over the guidewire.A cls-3.5 guide catheter was initially selected, though this was unable to adequately engage the left system.It was exchanged out for a cls-3.5 guide catheter which was able to engage the left system.Then the fractional flow reserve (ffr) wire was zeroed according to protocol, and then advanced into the proximal lad, where pressure was equalized.At that point, we attempted to advance the wire beyond the lesion, which we were able to.However, while manipulating the wire from a diagonal branch into the distal lad which it was sub-selecting, the wire fractured.Per interventionalist, there was barely any manipulation of the wire and there was nothing about the anatomy that would have caused the wire to get stuck or mangled.

• Brand Name: COMET FFR WIRE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 6085083
• MDR Text Key: 59407063
• Report Number: 6085083
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0.014/185CM
• Device Catalogue Number: H7495551110
• Device Lot Number: 19597030
• Other Device ID Number: GTIN 08714729875758
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 109