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

Model Number H7495551110

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a ffr comet pressure wire.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The shaft showed two kinks.The first kink was located at 57.5cm from the tip.The second kink was located at 139.5cm from the tip.There was also some peeling of the coating at the 57.5cm location.The tip showed some bending damage.The sensor port was clear of any material.The pressure wire was connected to the analysis support test bench and all applicable data was correct as designed, there was no difficulty in connecting the wire.There were no issues in connecting the wire to the test equipment.The coefficient was confirmed to be in specification.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks, tip damage and the peeling of the coating were attributable to handling of the device.There was no evidence of any damage or irregularities contributing to the reported signal difficulty, which could not be confirmed because the clinical circumstances could not be replicated.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Reportable based on device analysis completed on 15-feb-2018.It was reported that pressure guidewire signal strength was lost.The 70% stenosed target lesion was located in a moderately tortuous, moderately calcified left anterior descending artery.During the procedure, a 185cm comet¿ pressure guide wire lost signal strength as was noted on the ffr link.After multiple attempts to reconnect the comet¿ pressure guide wire, the signal strength was never regained.The wire was then replaced with another of the same and that product worked without issue.There were no complications to the patient and the patient left the procedure area in stable condition.However, returned device analysis revealed that coating peeled.

• 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 Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7332439
• MDR Text Key: 102202876
• Report Number: 2134265-2018-01737
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2018

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: 07/28/2019
• Device Model Number: H7495551110
• Device Lot Number: 0020943109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR