MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number H7493932440

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: returned product consisted of a ffr comet pressure wire in one piece.The tip, device shaft and the sensor port were examined for damage or any irregularities.The tip showed no issues.The shaft showed one kink/bend approximately 124.5 cm from the tip.There was also some peeling of the coating approximately 125 cm from the tip.The sensor port was clear of any material.The complaint of a kink in the device was confirmed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 15dec2016.It was reported that the base of the pressure wire kinked.The lesion was located in the moderately left anterior descending artery (lad).During the procedure, when the physician was about to insert the comet pressure wire into the y connector, the base part got kinked.There were no patient complications and the procedure was completed with another of the same device.Device analysis revealed some peeling of the coating approximately 125 cm from the tip.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6240732
• MDR Text Key: 64614570
• Report Number: 2134265-2016-12221
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: H7493932440
• Device Catalogue Number: 393244
• Device Lot Number: 19746916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1