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

Model Number 8900

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Date of event is estimated based on the aware date of (b)(6) 2019.Returned product consisted of an ffr comet pressure wire not connected to the occ cable.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The shaft showed 1 kink located at the 43.5cm from the tip.The coating was peeled at 43.5cm.The tip showed a bend.The collet was stuck inside of the cap.The wire was inserted into the occ handle and tested for signal issues.The signal was present as designed.The collet was removed from the cap and the cap was analyzed.The cap showed damage inside where the collect was stuck and would not open to release the wire.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Because there was no evidence of any product quality deficiencies, it was considered likely that the kink, tip damage and the coating issues were attributable to handling.

Event Description

Reportable based on analysis completed on 26sep2019.It was reported that the guidewire could not be disconnected.During a ffr procedure, the comet guidewire could not be disconnected from the handle as the wire was stuck.The guidewire was removed from the patient and the procedure was successfully completed with a different device without issue or patient injury.However, returned device analysis revealed coating peeling.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9205969
• MDR Text Key: 164328181
• Report Number: 2134265-2019-12447
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2019

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: 03/04/2021
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0023435725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2019
• 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