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

Model Number	H7493896108150
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: returned product consisted of the apex balloon catheter.The shafts, balloon and tip were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic examination of the balloon revealed that there was a pinhole at the proximal edge of the markerband.Microscopic examination presented no irregularities in the balloon material or the 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 is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2017.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The 3.5x24mm, de novo target lesion was located in the non-tortuous and severely calcified left anterior descending (lad) artery.A 1.50mm x 8mm apex¿ push balloon catheter was advanced but failed to cross the lesion.Pre-dilatation was then performed with 1.2mm and 1.0mm balloon catheters.After a stent was implanted, post-dilatation was performed with a large diameter balloon catheter and the procedure was completed.No patient complications were reported and the patient was doing perfectly all right.However, returned device analysis revealed balloon pinhole.

• Brand Name: APEX¿ PUSH
• 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: 6381855
• Report Number: 2134265-2017-01578
• Device Sequence Number: 528478
• Product Code: LOX
• UDI-Device Identifier: 08714729475996
• UDI-Public: (01)08714729475996(17)20180331(10)17813091
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2017

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: 03/31/2018
• Device Model Number: H7493896108150
• Device Catalogue Number: 38961-0815
• Device Lot Number: 17813091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1