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

Model Number	H7493895808150
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2016
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 medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in the left circumflex (lcx) artery.A 1.50mm x 8mm apex¿ flex balloon catheter was advanced for dilation.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 patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an apex otw balloon catheter and no other devices.The balloon was loosely folded with fluid in the balloon and inflation lumen.The balloon, markerbands, proximal weld, inner/outer shafts were microscopically and tactile inspected.Inspection revealed a jagged burst in the balloon material, approximately 2 mm in length.Inspection of the remainder of the device revealed no other damage or irregularities.Review of the product specification was performed.The reported information indicates the device was inflated over rated burst pressure.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: "rated burst pressure.Do not exceed." (b)(4).
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in the left circumflex (lcx) artery.A 1.50 mm x 8 mm apex¿ flex balloon catheter was advanced for dilation.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 patient's status was stable.

• Brand Name: APEX¿ FLEX
• 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: 6280502
• Report Number: 2134265-2017-00378
• Device Sequence Number: 19029305
• Product Code: LOX
• UDI-Device Identifier: 08714729474746
• UDI-Public: (01)08714729474746(17)20171130(10)18660686
• 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: 11/30/2017
• Device Model Number: H7493895808150
• Device Catalogue Number: 38958-0815
• Device Lot Number: 18660686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• 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