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

Model Number H7493808012300

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Returned product consisted of a quantum maverick balloon catheter in two pieces.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 81.3cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.There are numerous hypotube kinks.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

Event Description

Reportable based on device analysis completed on 17nov2017.It was reported that crossing difficulties and shaft kinked occurred.A 3.0mm x 12mm quantum¿ maverick¿ balloon catheter was advanced for dilatation.However, the device was unable to cross the lesion and it was noted that the device delivery shaft was kinked.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 a hypotube break.

Manufacturer Narrative

Date rec'd by mfr.Corrected from 10/16/2017 to 11/17/2017.(b)(4).

Event Description

Reportable based on device analysis completed on 17nov2017.It was reported that crossing difficulties and shaft kinked occurred.A 3.0mm x 12mm quantum¿ maverick¿ balloon catheter was advanced for dilatation.However, the device was unable to cross the lesion and it was noted that the device delivery shaft was kinked.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 a 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 (Section G): 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: 7086203
• MDR Text Key: 94509227
• Report Number: 2134265-2017-11930
• 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,Followup
• Report Date: 11/17/2017

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: 01/31/2020
• Device Model Number: H7493808012300
• Device Catalogue Number: 38080-1230
• Device Lot Number: 0020154457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2017
• 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