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

Model Number	H7493808012450
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that shaft expansion occurred.A 4.5x12mm quantum maverick balloon catheter was used in the patient and it was noted the balloon was inflated but the expansion was inadequate.The shaft proximal to the balloon was also expanded along with the balloon.The procedure was completed with another of the same device.No patient complications were reported.
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, and conclusion codes updated.Device evaluated by mfr : returned product consisted of a quantum maverick balloon catheter.There was contrast in the inflation lumen and balloon.The distal shaft, balloon, balloon bonds and markerbands were examined.The balloon was loosely folded.Microscopic examination of the balloon presented no irregularities in the balloon material or the ro markerband.A portion of the outer shaft was plastically deformed proximal of the proximal balloon weld.The confirmed shaft damage is consistent with the reported information.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that shaft expansion occurred.A 4.5x12mm quantum maverick balloon catheter was used in the patient and it was noted the balloon was inflated but the expansion was inadequate.The shaft proximal to the balloon was also expanded along with the balloon.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 7182103
• Report Number: 2134265-2018-00016
• Device Sequence Number: 13747412
• Product Code: LOX
• UDI-Device Identifier: 08714729392729
• UDI-Public: 08714729392729
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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: 08/08/2020
• Device Model Number: H7493808012450
• Device Catalogue Number: 38080-1245
• Device Lot Number: 20987057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1