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

Model Number 8900

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2023

Event Type  Injury  

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the tip of the guidewire was stretched during use.A comet ii pressure guidewire was used for cardiac intervention.During the procedure, the tip of the guidewire was stretched, and the tip could not be shaped.After repeated attempts, it still could not reach the distal end of the blood vessel.Another pressure guidewire was used, and the procedure was completed.No patient complications were reported, and patient was stable post procedure.However, device analysis revealed that the tip was stretched for 7mm in length and detached at an unknown location.

Manufacturer Narrative

Device evaluated by mfr.: the complaint device was received for product analysis.Returned product consisted of an ffr comet pressure wire with the occ cable.The occ cable, tip, and device shaft were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the tip was stretched for 7mm in length and detached at an unknown location (due to the stretching of the tip, the detachment location cannot be measured).The ends of the detachment appeared to be smooth with material pushed up at an edge.The detached portion of the tip was not returned for analysis.The occ cable was then connected to the bench top testing equipment and the coefficient values were confirmed to be programmed.No other issues were identified during the product analysis.Product analysis confirmed the reported event, as the tip was stretched and detached.

Event Description

Reportable based on device analysis completed on 01sep2023.It was reported that the tip of the guidewire was stretched during use.A comet ii pressure guidewire was used for cardiac intervention.During the procedure, the tip of the guidewire was stretched, and the tip could not be shaped.After repeated attempts, it still could not reach the distal end of the blood vessel.Another pressure guidewire was used, and the procedure was completed.No patient complications were reported, and patient was stable post procedure.However, device analysis revealed that the tip was stretched for 7mm in length and detached at an unknown location.It was further reported that the tip of the device was stretched and there is no detached portion.Also, no fracture was noted.Device was completely removed from the patient body.

Manufacturer Narrative

Device evaluated by mfr.: the complaint device was received for product analysis.Returned product consisted of an ffr comet pressure wire with the occ cable.The occ cable, tip, and device shaft were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the tip was stretched for 7mm in length and detached at an unknown location (due to the stretching of the tip, the detachment location cannot be measured).The ends of the detachment appeared to be smooth with material pushed up at an edge.The detached portion of the tip was not returned for analysis.The occ cable was then connected to the bench top testing equipment and the coefficient values were confirmed to be programmed.No other issues were identified during the product analysis.Product analysis confirmed the reported event, as the tip was stretched and detached.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17824753
• MDR Text Key: 324353787
• Report Number: 2124215-2023-52743
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2023
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0028488566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 10/07/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 79 KG