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

Model Number H7493808012270

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).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 Description

It was reported that balloon pinhole occurred.The target lesion was located in the mid right coronary artery (rca).A 2.75mm x 12mm quantum¿ maverick¿ balloon catheter was advanced to dilate the lesion.The balloon was inflated 3 to 4 times at 20 atmospheres; however, it was noted that the balloon could not dilate the lesion and a pinhole was noted on the balloon material.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

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, conclusion codes updated.Device evaluated by mfr: returned product consisted of the quantum maverick balloon catheter.The shaft, bonds, and balloon were microscopically and visually examined.There was blood in the hub, inflation lumen, guidewire lumen and balloon.The balloon was loosely folded.Microscopic examination of the balloon revealed a pinhole in the balloon wall 2.5mm proximal of the distal markerband.Microscopic examination presented no irregularities in the balloon material that could have contributed to the damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.There is no indication the device was inflated over rbp.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 Description

It was reported that balloon pinhole occurred.The target lesion was located in the mid right coronary artery (rca).A 2.75mm x 12mm quantum¿ maverick¿ balloon catheter was advanced to dilate the lesion.The balloon was inflated 3 to 4 times at 20 atmospheres; however, it was noted that the balloon could not dilate the lesion and a pinhole was noted on the balloon material.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: QUANTUM¿ MAVERICK¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6280796
• MDR Text Key: 65857632
• Report Number: 2134265-2017-00442
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392668
• UDI-Public: (01)08714729392668(17)20190731(10)19491809
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: H7493808012270
• Device Catalogue Number: 38080-1227
• Device Lot Number: 19491809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1