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

Model Number	H7493808012370
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: 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 shaft break occurred.A 3.75mm x 12mm quantum¿ maverick¿ balloon catheter was selected for use.However, upon unpacking, it was noted that the balloon shaft was fractured.The procedure was completed with another same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device avail.For eval, returned to mfr.On, device returned to mfr, device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter in two pieces.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Although it was reported that the device was not used, the presence of blood and contrast media in the guidewire lumen and inflation lumen is indicative of handling beyond simply unpackaging the device, as was reported.The shaft, hypotube, and bonds were microscopically and visually examined.The hypotube was kinked 52.5 cm from the strain relief and there was a complete hypotube separation 56.5 cm from the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.The distal 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
It was reported that shaft break occurred.A 3.75 mm x 12 mm quantum maverick balloon catheter was selected for use.However, upon unpacking, it was noted that the balloon shaft was fractured.The procedure was completed with another same device.No patient complications were reported and the patient's status was stable.

• Brand Name: QUANTUM¿ MAVERICK¿
• 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: 6101384
• Report Number: 2134265-2016-10040
• Device Sequence Number: 13640175
• Product Code: LOX
• UDI-Device Identifier: 08714729392705
• UDI-Public: (01)08714729392705(17)20190430(10)19192521
• 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): 10/19/2016

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: 04/30/2019
• Device Model Number: H7493808012370
• Device Catalogue Number: 38080-1237
• Device Lot Number: 19192521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1