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

Model Number	H7493892820300
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); No Consequences Or Impact To Patient (2199); Obstruction/Occlusion (2422)
Date of Event	11/26/2016
Type of Reportable Event	Serious Injury
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 removal difficulties were encountered.The 94% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 3.00 mm x 20 mm maverick² balloon catheter was advanced for dilation.However, degradation of deep-sea balloon was noted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Ae or product problem corrected from product problem to reported issue is both an adverse event and product problem.(b)(4).Type of reportable event corrected from malfunction to serious injury.Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter.The balloon was loosely folded with contrast and blood in the balloon and lumen.There were multiple hypotube kinks.There was tip damage.Microscopic inspection revealed a longitudinal tear in the balloon material.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 further reported that there were no removal difficulties encountered; however, during inflation, the balloon ruptured.It was also noticed that the vessel's blood flow was not good.The device was then completely removed from the patient.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2016-12634.It was further reported that a 3.5mm x 12mm quantum¿ maverick¿ balloon catheter was also advanced for dilation; however, during inflation, the balloon also ruptured.The device was completely removed from the patient.The patient¿s blood pressure (bp) had also dropped.After waiting, patient¿s condition got better.Then a synergy stent was deployed and a non-compliant balloon catheter completed the procedure.

• 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: 6233967
• Report Number: 2134265-2016-12264
• Device Sequence Number: 323687
• Product Code: LOX
• UDI-Device Identifier: 08714729370208
• UDI-Public: (01)08714729370208(17)20190930(10)19735644
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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,Followup
• Report Date (Section B): 12/16/2016

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: 09/30/2019
• Device Model Number: H7493892820300
• Device Catalogue Number: 38928-2030
• Device Lot Number: 19735644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/16/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 02/10/2017; 03/03/2017
• 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
• Patient Age: 61 YR