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

Model Number H7493808012350

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that shaft break.During unpacking of a 3.5mm x 12mm quantum¿ maverick¿ balloon catheter, it was noted that the shaft was fractured.The procedure was completed with another of the same device.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.The balloon was tightly folded with contrast in the inflation lumen.The hub, hypotube, port/exit notch, inner/outer shaft were microscopically and tactile inspected.Inspection revealed numerous kinks in the hypotube.Inspection of the remainder of the device presented no other damage or irregularities.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 shaft break.During unpacking of a 3.5mm x 12mm quantum¿ maverick¿ balloon catheter, it was noted that the shaft was fractured.The procedure was completed with another of the same device.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 (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: 7109730
• MDR Text Key: 95070928
• Report Number: 2134265-2017-12120
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392699
• UDI-Public: 08714729392699
• 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: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: H7493808012350
• Device Catalogue Number: 38080-1235
• Device Lot Number: 20465874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• 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