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

Model Number H7493926708320

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that tip detachment occurred.After a stent was placed, a 3.25mm x 8mm nc emerge® balloon catheter was advanced for post-dilation.However, it was noted that the balloon tip broke off.The broken pieces were retrieved and the procedure was completed.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the target lesion was 90% stenosed, located in the heavily calcified with non-serious tortuosity right coronary artery.The 3.25mm x 8mm nc emerge balloon catheter was trying to cross the lesion and was never inflated when the shaft broke.The guide wire, guide extension catheter, and guide catheter were removed and everything came out without snaring.

Event Description

It was further reported that the target lesion was 90% stenosed, located in the heavily calcified with non-serious tortuosity right coronary artery.The 3.25mm x 8mm nc emerge balloon catheter was trying to cross the lesion and was never inflated when the shaft broke.The guide wire, guide extension catheter, and guide catheter were removed and everything came out without snaring.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter in two pieces.The balloon was loosely folded with blood in the lumen and balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 70.7cm from the hub.The fracture faces were oval as if kinked prior to separation.There are numerous hypotube and shaft kinks.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• 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: 7621778
• MDR Text Key: 111899980
• Report Number: 2134265-2018-05367
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2020
• Device Model Number: H7493926708320
• Device Catalogue Number: 39267-0832
• Device Lot Number: 0021998555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR