MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493895915250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the proximal right coronary artery.A 2.50mm x 15mm apex¿ balloon catheter was advanced to dilate the lesion.However, at 24 atmospheres, the balloon ruptured.The device was completely removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient' status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the apex balloon catheter.The balloon, bonds, and tip were microscopically and visually examined.There was blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic examination of the balloon revealed a pinhole at the proximal balloon transition.Microscopic examination presented no irregularities in the balloon material or markerband that could have contributed to the damage.The tip was damaged.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the direction for use states: ¿do not exceed the rated balloon burst pressure.If difficulty is experienced during balloon inflation, do not continue inflation; deflate and remove the catheter.¿ (b)(4).
Event or Problem Description
It was further reported that the balloon ruptured on initial inflation.

• Brand Name: APEX¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6582685
• Report Number: 2134265-2017-05220
• Device Sequence Number: 749299
• Product Code: LOX
• UDI-Device Identifier: 08714729475613
• UDI-Public: (01)08714729475613(17)20190430(10)19168740
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P860019
• 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,Followup
• Report Date (Section B): 05/09/2017

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: 04/30/2019
• Device Model Number: H7493895915250
• Device Catalogue Number: 38959-1525
• Device Lot Number: 19168740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR