MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493892815150

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Age at the time of event: 18 years or older. (b)(4). Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter in two pieces. The balloon was tightly folded. The hypotube and inner/outer shaft was microscopically examined. The hypotube broke/fractured 82cm from the strain relief with kinks 46cm and 79cm from the strain relief. 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. Inspection of the remainder of the device, apart from the observed damage, revealed 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 (b)(6) 2016. It was reported that shaft kink occurred. The target lesion was located in a coronary artery. A 1. 50mmx15mm maverick2(tm) balloon catheter was advanced to the lesion. However, during procedure, it was noted that the shaft was kinked. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed hypotube break.

• Brand Name: MAVERICK²¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5976404
• Report Number: 2134265-2016-08299
• 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: 08/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2019
• Device Model Number: H7493892815150
• Device Catalogue Number: 38928-1515
• Device Lot Number: 19191679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial