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

Model Number	7132
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed two pinholes in the balloon approximately 7.5mm from the tip.The balloon is loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found two pinholes in the balloon.The investigation conclusion is adverse event related to procedure.
Event or Problem Description
Reportable based on device analysis completed on 18-dec-2018.It was reported that balloon inflation issues were encountered.The target lesion was located in the percutaneous coronary intervention (pci).A 1.20mm x 12mm fg emerge catheter was used was advance for dilation.However, deflation difficulties occured the balloon couldn't dilate sufficiently.The procedure was continued with another of same device.There were no patient complications nor injuries reported.However, returned device analysis revealed balloon pinhole.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8247734
• Report Number: 2134265-2018-65116
• Device Sequence Number: 2279517
• Product Code: LOX
• UDI-Device Identifier: 08714729806066
• UDI-Public: 08714729806066
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0018978367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1