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

Model Number	H7493892809200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	01/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.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 vessel dissection occurred.The target lesion was located in the moderately tortuous and mildly calcified mid right coronary artery (rca).A 2.00mm x 9mm maverick²¿ balloon catheter was advanced to dilate the lesion but failed to cross.However, a vessel dissection was noticed in the rca.The physician then referred the patient for coronary artery bypass graft (cabg).No further 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 balloon catheter.The balloon was loosely folded with fluid in the balloon and lumen.The balloon, markerband, proximal weld, inner/outer shaft, and hypotube were microscopically inspected.Inspection revealed numerous kinks in the hypotube.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
It was reported that vessel dissection occurred.The target lesion was located in the moderately tortuous and mildly calcified mid right coronary artery (rca).A 2.00mm x 9mm maverick²¿ balloon catheter was advanced to dilate the lesion but failed to cross.However, a vessel dissection was noticed in the rca.The physician then referred the patient for coronary artery bypass graft (cabg).No further 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: 6278677
• Report Number: 2134265-2017-00248
• Device Sequence Number: 1075635
• Product Code: LOX
• UDI-Device Identifier: 08714729369875
• UDI-Public: (01)08714729369875(17)20171231(10)17566629
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 01/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: H7493892809200
• Device Catalogue Number: 38928-0920
• Device Lot Number: 17566629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other