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

Model Number H7493808008400

Device Problem Break (1069)

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).

Event Description

It was reported that shaft break occurred.The 90% stenosed, 18mm x 3.5mm target lesion was located in the severely tortuous and moderately calcified right coronary artery.A 4.0mm x 8mm quantum¿ maverick¿ balloon catheter was advanced to dilate the lesion.However, it was noted that the shaft had fractured.The device was completely removed from the patient's body 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 lot number corrected from 19259204 to 19133634.Device expiration date corrected from 05/31/2019 to 04/30/2019.Device manufactured date corrected from 05/16/2016 to 04/12/2016.Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter in two pieces.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.The shaft, hypotube, and bonds were microscopically and visually examined.There were numerous hypotube and shaft kinks throughout the device.There was also, a complete hypotube separation 55.5cm from the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.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.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.The 90% stenosed, 18mm x 3.5mm target lesion was located in the severely tortuous and moderately calcified right coronary artery.A 4.0mm x 8mm quantum¿ maverick¿ balloon catheter was advanced to dilate the lesion.However, it was noted that the shaft had fractured.The device was completely removed from the patient's body 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: 6178460
• MDR Text Key: 62539022
• Report Number: 2134265-2016-11686
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392606
• UDI-Public: (01)08714729392606(17)20190531(10)19259204
• 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: 11/30/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: H7493808008400
• Device Catalogue Number: 38080-0840
• Device Lot Number: 19133634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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