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

Model Number H7493808012300

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that tip detachment occurred.A 3.0mm x 12mm quantum¿ maverick¿ balloon catheter was advanced for dilatation.However, the tip of the balloon catheter was fractured.The device and the fractured tip were removed from the patient and the procedure was completed with another 3.0mm x 12mm quantum¿ maverick¿ balloon.No patient complications were reported and the patient¿s status was stable.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter in two pieces.The balloon was loosely folded and the tip was not detached from the catheter.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 90.9cm from the hub.The fracture faces were oval as if kinked prior to separation.There are numerous hypotube kinks.The tip is damaged, but not separated from the catheter.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that tip detachment occurred.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, the tip of the balloon catheter was fractured.The device and the fractured tip were removed from the patient and the procedure was completed with another 3.0mm x 12mm quantum maverick balloon.No patient complications were reported and 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: 7558161
• MDR Text Key: 109706580
• Report Number: 2134265-2018-05341
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392675
• UDI-Public: 08714729392675
• 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: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: H7493808012300
• Device Catalogue Number: 38080-1230
• Device Lot Number: 0021687324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2018
• 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 Outcome(s): Other