MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7162

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that shaft break occurred.A 2.75mm x 12mm emerge balloon catheter was selected for use; however, it was noted that the shaft broke approximately 25cm from the hub.There were no patient complications nor injuries reported.

Manufacturer Narrative

Initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of an emerge balloon catheter in two pieces.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The hypotube was completely separated 26cm from the hub.The hypotube fracture surface was ovaled and torn, which suggests the device was kinked prior to separation.There are numerous hypotube and shaft kinks.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that shaft break occurred.A 2.75mm x 12mm emerge balloon catheter was selected for use; however, it was noted that the shaft broke approximately 25cm from the hub.There were no patient complications nor injuries reported.

Event Description

It was reported that shaft break occurred.A 2.75mm x 12mm emerge balloon catheter was selected for use; however, it was noted that the shaft broke approximately 25cm from the hub.There were no patient complications nor injuries reported.It was further reported that the shaft broke outside the patient and the procedure was completed with another emerge balloon.The patient was fine.

Manufacturer Narrative

E1: initial reporter city: (b)(6).Device evaluated by mfr.:returned product consisted of an emerge balloon catheter in two pieces.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The hypotube was completely separated 26cm from the hub.The hypotube fracture surface was ovaled and torn, which suggests the device was kinked prior to separation.There are numerous hypotube and shaft kinks.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8895147
• MDR Text Key: 154429383
• Report Number: 2134265-2019-09527
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2021
• Device Model Number: 7162
• Device Catalogue Number: 7162
• Device Lot Number: 0023729318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1