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	07/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).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 rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.50mm x 8mm apex¿ balloon catheter was advanced for dilation.The balloon was initially inflated at 6 atmospheres.However, during the second inflation at 6 atmospheres for 10 seconds, the balloon ruptured.The procedure was completed with a non-bsc balloon catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned product consisted of an apex balloon catheter.The balloon was loosely folded with blood in the inflation lumen and balloon.Microscopic examination revealed the balloon has a pinhole at the proximal balloon waist.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 100% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.50mm x 8mm apex balloon catheter was advanced for dilation.The balloon was initially inflated at 6 atmospheres.However, during the second inflation at 6 atmospheres for 10 seconds, the balloon ruptured.The procedure was completed with a non-bsc balloon catheter.No patient complications were 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: 6787356
• Report Number: 2134265-2017-08015
• Device Sequence Number: 16180593
• Product Code: LOX
• UDI-Device Identifier: 08714729474777
• UDI-Public: (01)08714729474777(17)20180930(10)0019688959
• 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,Followup
• Report Date (Section B): 07/26/2017

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: 09/30/2018
• Device Model Number: H7493895808250
• Device Catalogue Number: 38958-0825
• Device Lot Number: 0019688959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1