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

Model Number H7493808015300

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that shaft break occurred.A 3.0mm x 15mm quantum¿ maverick¿ balloon catheter was advanced for dilatation.However upon advancing, the shaft broke.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 evaluated by mfr: returned product consisted of the proximal portion of the quantum maverick balloon.Portion of the hypotube, the distal shaft, the balloon, the markerbands, and the tip were not returned for product analysis.The shaft, hypotube, and bonds were microscopically and visually examined.There was also, a complete hypotube separation 79.5cm from the strain relief.The hypotube fracture surface was ovaled, which suggests the device was kinked prior to separation.The shaft and bonds could not be analyzed as there were not returned for analysis.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.Device analysis determined the condition of the returned device was consistent with the reported information.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 shaft break occurred.A 3.0mm x 15mm quantum¿ maverick¿ balloon catheter was advanced for dilatation.However upon advancing, the shaft broke.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: 6200214
• MDR Text Key: 63209900
• Report Number: 2134265-2016-12064
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392781
• UDI-Public: (01)08714729392781(17)20190630(10)19427834
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: H7493808015300
• Device Catalogue Number: 38080-1530
• Device Lot Number: 19427834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• 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