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

Model Number	H7493895808250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2017
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 was not received for 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
It was reported that balloon rupture occurred.The chronic totally occluded (cto) target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery (lad).After a non-bsc guide wire crossed the lesion, a 2.50mm x 8mm apex¿ balloon catheter was advanced for dilatation.The balloon was first inflated at 10 atmospheres and second to the third inflation at 12 atmospheres.However, during the fourth inflation at 12 atmospheres for 40 seconds, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another 2.5x10mm non-bsc balloon catheter.There were no patient complications nor damaged reported.

• 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: 6596300
• Report Number: 2134265-2017-05271
• Device Sequence Number: 369264
• Product Code: LOX
• UDI-Device Identifier: 08714729474777
• UDI-Public: (01)08714729474777(17)20170430(10)17902675
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/10/2017

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: 04/30/2017
• Device Model Number: H7493895808250
• Device Catalogue Number: 38958-0825
• Device Lot Number: 17902675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1