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

Model Number	H7493808020300
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: returned product consisted of the hub, hypotube and proximal shaft of a quantum maverick balloon catheter.The distal shaft, balloon and tip were not returned.The hypotube and shaft was microscopically examined.The shaft was completely separated/torn 109.8cm from the hub.The fractured/separated end of the distal shaft is stretched and jagged which indicates the shaft separation was due to tensile forces.The distal shaft, balloon and tip were not returned for analysis.The shaft is stretched and buckled.There are numerous hypotube kinks.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2018.It was reported that crossing difficulties were encountered.The patient presented with inferior st elevation myocardial infarction.Vascular access was obtained via the left radial artery.The totally occluded target lesion was located in the mid right coronary artery (rca).After non-bsc guide catheter and guide wire crossed the lesion, pre-dilatation was performed 2.5x15 balloon catheter.A 3x36mm non-bsc stent was deployed at 12 atmospheres.A 3.0mm x 20mm quantum¿ maverick¿ balloon catheter was advanced for post-dilatation.However, the device failed to cross the stent after multiple attempts.Applying more force on the balloon causes the guide catheter to dislodge.The device was removed and the procedure competed with a 3x20mm non-bsc balloon catheter resulting in timi iii flow into the distal rca.No known patient complications were reported and the patient's status was stable.However, returned device analysis revealed shaft detachment.

• 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: 7690095
• Report Number: 2134265-2018-06187
• Device Sequence Number: 2643775
• Product Code: LOX
• UDI-Device Identifier: 08714729392897
• UDI-Public: 08714729392897
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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
• Report Date (Section B): 06/22/2018

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: 10/11/2020
• Device Model Number: H7493808020300
• Device Catalogue Number: 38080-2030
• Device Lot Number: 21250468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: JR4; GUIDE WIRE: ASAHI SOFT; STENT: BIOMETRIX NEOFLEX 3X36MM
• Patient Age: 51 YR