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

Model Number H7493808008250

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter. The balloon was tightly folded. There was contrast in the inflation lumen. Device analysis determined the condition of the returned device was consistent with the complaint incident. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube shaft was completely separated 69 cm from the tip. The fracture faces were oval as if kinked prior to separation. There were numerous hypotube kinks. There was no evidence of any material or manufacturing deficiencies contributing to the damage. Inspection of the remainder of the device presented no other damage or irregularities. 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

Reportable based on device analysis completed on 28-oct-2016. It was reported that shaft kink occurred. The target lesion was located in the coronary artery. A 2. 5mm x 8mm quantum¿ maverick¿ balloon catheter was advanced to dilate the lesion. However, it was noted that the shaft was kinked. The procedure was completed with a different device. No patient complications were reported. However, returned device analysis revealed hypotube break.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the device may have been fractured upon removal. It was simply removed the device from the patient's body. 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: 6113499
• MDR Text Key: 60437922
• Report Number: 2134265-2016-10377
• 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,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2019
• Device Model Number: H7493808008250
• Device Catalogue Number: 38080-0825
• Device Lot Number: 18994148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial