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

Model Number 7162

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that shaft break occurred.A 2.50mm x 12mm emerge balloon catheter was advanced for dilatation.However, upon removal of the device from the patient's body, the wire got snapped.No patient complications were reported.

Event Description

It was reported that shaft break occurred.A 2.50mm x 12mm emerge balloon catheter was advanced for dilatation.However, upon removal of the device from the patient's body, the wire got snapped.No patient complications were reported.

Manufacturer Narrative

Initial reporter phone: (b)(6).Date of event: used the first date of the month of the aware date as no event date was provided.Corrections: device lot number corrected from 0023070949 to 0023363772.Device expiration date corrected from 08/08/2021 to 10/16/2021.Device manufactured date corrected from 12/12/2018 to 02/19/2019.Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous hypotube kinks.There was a complete separation at 73.7cm distal from the strain relief.There was contrast in the inflation lumen.The balloon was loosely folded.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: 8583808
• MDR Text Key: 144248034
• Report Number: 2134265-2019-04794
• 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
• Report Date: 06/28/2019

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: 10/16/2021
• Device Model Number: 7162
• Device Catalogue Number: 7162
• Device Lot Number: 0023363772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 06/06/2019
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1