MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493892812250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 12x2.0mm target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.50mm x 12mm maverick balloon catheter was advanced for dilatation; however, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a maverick 2.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 18cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.There is tip damage.Functional testing was carried out by attaching an inflation device filled with water to the hub of the complaint device, and inflating the device to rated burst pressure.The maverick 2 device inflated and held pressure for 5 minutes, without leaking.There was no evidence of any material or manufacturing deficiencies contributing to the damage.There are numerous hypotube and shaft kinks.Reviews of documentation to ensure that all required in-process and final inspections and testing were completed and all acceptance criteria were met.There is no evidence that the device failed to meet applicable product specifications prior to shipment from bsc, therefore an additional dhr review is not required.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 90% stenosed, 12x2.0mm target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.50mm x 12mm maverick2 balloon catheter was advanced for dilatation; however, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

• Brand Name: MAVERICK²¿
• 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: 6808081
• Report Number: 2134265-2017-08328
• Device Sequence Number: 162960
• Product Code: LOX
• UDI-Device Identifier: 08714729369981
• UDI-Public: (01)08714729369981(17)20200331(10)0020413752
• 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): 08/03/2017

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: 03/31/2020
• Device Model Number: H7493892812250
• Device Catalogue Number: 38928-1225
• Device Lot Number: 0020413752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 08/21/2017
• 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