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

Model Number	H7493808008250
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The balloon was tightly folded.There was contrast in the inflation lumen.Device analysis determined the condition of the returned device was consistent with the complaint incident.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube shaft was completely separated 69 cm from the tip.The fracture faces were oval as if kinked prior to separation.There were numerous hypotube kinks.There was no evidence of any material or manufacturing deficiencies contributing to the damage.Inspection of the remainder of the device presented no other damage or irregularities.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
Reportable based on device analysis completed on 28-oct-2016.It was reported that shaft kink occurred.The target lesion was located in the coronary artery.A 2.5mm x 8mm quantum¿ maverick¿ balloon catheter was advanced to dilate the lesion.However, it was noted that the shaft was kinked.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed hypotube break.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the device may have been fractured upon removal.It was simply removed the device from the patient's body.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: 6113499
• Report Number: 2134265-2016-10377
• Device Sequence Number: 989977
• Product Code: LOX
• UDI-Device Identifier: 08714729392545
• UDI-Public: (01)08714729392545(17)20190331(10)18994148
• 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): 10/28/2016

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: 03/31/2019
• Device Model Number: H7493808008250
• Device Catalogue Number: 38080-0825
• Device Lot Number: 18994148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2016
• Supplement Report FDA Received Date: 12/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1