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

Model Number H7493808012450

Device Problems Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Device evaluated by mfr. : returned product consisted of a quantum maverick balloon catheter. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. The tip is damaged. The hypotube shaft was completely separated 75. 8cm from the hub. The fracture faces were oval as if kinked prior to separation. There was no evidence of any material or manufacturing deficiencies contributing to the damage. There were numerous hypotube and shaft kinks. There is no evidence that the device failed to meet applicable product specifications prior to shipment. The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors. (b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2017. It was reported that shaft kink occurred. A 4. 5mm x 12mm quantum maverick balloon catheter was selected for use. However, the delivery shaft was noted to be kinked during unpacking. The procedure was completed with another of the same device. No patient complications were reported and patient's status was stable. However, returned device analysis revealed hypotube break.

• 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: 6853587
• MDR Text Key: 85585732
• Report Number: 2134265-2017-08910
• Device Sequence Number: 1
• Product Code: LOX
• 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

• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2019
• Device Model Number: H7493808012450
• Device Catalogue Number: 38080-1245
• Device Lot Number: 0019943449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial