MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493927608350

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon pinhole occurred.A 3.50mm x 8mm nc emerge® balloon catheter was advanced for dilatation.However, upon inflation, it was noted that the contrast media leaked into the artery and a hole was noted on the balloon.The procedure was completed with another nc emerge balloon catheter.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a nc emerge balloon catheter.The balloon was loose and there was fluid in the balloon and inflation lumen.The balloon, hypotube, inner and outer shaft were microscopically inspected.Inspection revealed tip damage, abrasions in the balloon material located over the distal markerband, and a perforation in the balloon material approximately 1mm in length (also located at the distal end of the markerband).The abrasions are consistent with difficult anatomy.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.There is no indication the device was inflated over rated burst pressure (rbp).The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that balloon pinhole occurred.A 3.50mm x 8mm nc emerge balloon catheter was advanced for dilatation.However, upon inflation, it was noted that the contrast media leaked into the artery and a hole was noted on the balloon.The procedure was completed with another nc emerge balloon catheter.There were no patient complications.

• Brand Name: NC EMERGE®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7592630
• MDR Text Key: 110801417
• Report Number: 2134265-2018-05082
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2020
• Device Model Number: H7493927608350
• Device Catalogue Number: 39276-0835
• Device Lot Number: 22015461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Date Manufacturer Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1