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

Model Number H7493808015370

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The balloon was tightly folded.The hypotube, inner shaft, and outer shaft were microscopically and tactile inspected.Inspection revealed numerous kinks in the hypotube at 41.5cm and 65cm from the strain relief with a shaft fracture 61.5cm (from the strain relief).The fracture faces were oval in shape, as if kinked prior to separation.Inspection of the remainder of the device found 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 25-aug-2016.It was reported that shaft kinked occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified coronary artery.A 3.75mmx15mm quantum¿ maverick¿ balloon catheter was advanced for dilatation; however the balloon shaft got kinked.The procedure was completed with another quantum¿ maverick¿ balloon catheter.No patient complications were reported and the 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5960098
• MDR Text Key: 55044596
• Report Number: 2134265-2016-08217
• 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: Physician
• Type of Report: Initial
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• 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: H7493808015370
• Device Catalogue Number: 38080-1537
• Device Lot Number: 19112320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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
• Patient Age: 68 YR
• Patient Weight: 85