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

Model Number	7522
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was an in-stent restenosis located in the proximal end of left anterior descending (lad) artery.A 2.50mm x 15mm apex balloon catheter was advanced for pre-dilatation.However, during inflation at 18 atmospheres, the balloon ruptured and the device was removed from the patient.A 3.0 x 12mm bsc balloon catheter was then advanced for post-dilatation, followed by the implantation of a 4.0 x 28mm bsc stent and post-dilatation again with a 4.5 x 12mm bsc balloon catheter, and the procedure was completed.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/12/2018 03:46 pm ct.The report number is being corrected from: 2134265-2018-63966 to: 2134265-2018-62656.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was an in-stent restenosis located in the proximal end of left anterior descending (lad) artery.A 2.50mm x 15mm apex balloon catheter was advanced for pre-dilatation.However, during inflation at 18 atmospheres, the balloon ruptured and the device was removed from the patient.A 3.0 x 12mm bsc balloon catheter was then advanced for post-dilatation, followed by the implantation of a 4.0 x 28mm bsc stent and post-dilatation again with a 4.5 x 12mm bsc balloon catheter, and the procedure was completed.No patient complications were reported and the patient's status was stable.Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed kinks at 10.5cm and 43.5cm from the hub.Microscopic examination revealed a longitudinal tear 3mm from the tip and approximately 20mm long.There is blood present in the inflation lumen and balloon.The balloon is loosely folded.Review of the product specification indicates the rated burst pressure (rbp) of the complaint device.The reported information indicates the device was inflated to 18 atm; therefore, the device was inflated over rbp.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8051359
• Report Number: 2134265-2018-62656
• Device Sequence Number: 16591192
• Product Code: LOX
• UDI-Device Identifier: 08714729475613
• UDI-Public: 08714729475613
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/18/2019

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: 05/31/2019
• Device Model Number: 7522
• Device Catalogue Number: 7522
• Device Lot Number: 0019293772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 01/18/2019
• 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