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

Model Number	H7493895912200
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event : 18 years or older.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 med watch will be filed.B)(4).
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in the severely calcified left anterior descending artery.A 2.00 mm x 12 mm apex balloon catheter was advanced to dilate the lesion.However, upon inflation of about 3-4 times at 20 atmospheres, the balloon was unable to inflate.The device was completely removed from the patient.However, a pinhole was noted on the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Returned product consisted of an apex balloon catheter in two pieces.The device soaked in a warm water bath for a week.The balloon was loosely folded with contrast in the balloon and inflation lumen and blood in the wire lumen.The tip, balloon, markerbands, proximal bond, distal shaft and hypotube were microscopically and tactile inspected.Inspection revealed the hypotube was separated 26.5cm from the strain relief with numerous kinks, and there was a burst in the balloon material approximately 1mm in length.The separated ends of the hypotube were oval, as if kinked prior to separation.Inspection of the remainder of the device revealed no other damage or irregularities.There is indication the device was inflated over the rated burst pressure (rbp).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 directions for use states: "do not exceed rated burst pressure." (b)(4).
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in the severely calcified left anterior descending artery.A 2.00mm x 12mm apex¿ balloon catheter was advanced to dilate the lesion.However, upon inflation of about 3-4 times at 20 atmospheres, the balloon was unable to inflate.The device was completely removed from the patient.However, a pinhole was noted on the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: 6280572
• Report Number: 2134265-2017-00388
• Device Sequence Number: 787655
• Product Code: LOX
• UDI-Device Identifier: 08714729475477
• UDI-Public: (01)08714729475477(17)20190430(10)19137423
• 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): 01/05/2017

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: H7493895912200
• Device Catalogue Number: 38959-1220
• Device Lot Number: 19137423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 03/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1