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

Model Number H7493926712250

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

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 mislabeling occurred.During unpacking of an nc emerge® balloon catheter, it was noticed that the size on the package (2.50mm x 12mm) and the device inside (2.25mmx12mm) did not match.The device was not used and no patient complications were reported.

Manufacturer Narrative

Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr: returned product consisted of an opened carton labeled as nc emerge mr 2.50mm x 12mm batch 21985731 with an opened pouch and used device from emerge mr 2.25mm x 12mm batch 21477078.The balloon is loosely folded with contrast in the inflation lumen and balloon.The hoop was not returned.Although it was reported that the device was not used, the presence of contrast media in the lumen and balloon is indicative of handling beyond simply unpackaging the device, as was reported.The device packaging, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.There are numerous hypotube kinks.Inspection of the remainder of the device revealed no damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that mislabeling occurred.During unpacking of an nc emerge balloon catheter, it was noticed that that the size on the package (2.50mm x 12mm) and the device inside (2.25mmx12mm) did not match.The device was not used and no patient complications were reported.

• 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: 7763147
• MDR Text Key: 116547653
• Report Number: 2134265-2018-07096
• 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
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2020
• Device Model Number: H7493926712250
• Device Catalogue Number: 39267-1225
• Device Lot Number: 0021985731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Date Manufacturer Received: 09/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1