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

Model Number H7493892815200

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a foreign material was found inside the product.A 2.00mm x 15mm maverick²¿ balloon catheter was selected for use.However, during unpacking, a foreign matter was noted inside the product.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter in the original pouch package.The pouch seals were intact and unopened.The tyvek pouch was microscopically and visually inspected.Inspection revealed foreign matter in the sealed pouch.Inspection of the remainder of the device revealed no other damage or irregularities.No other issues were identified during the product analysis.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.(b)(4).

Event Description

It was reported that a foreign material was found inside the product.A 2.00mm x 15mm maverick balloon catheter was selected for use.However, during unpacking, a foreign matter was noted inside the product.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7613523
• MDR Text Key: 111487142
• Report Number: 2134265-2018-05384
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370062
• UDI-Public: 08714729370062
• 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: 05/23/2018

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: 01/31/2021
• Device Model Number: H7493892815200
• Device Catalogue Number: 38928-1520
• Device Lot Number: 21690134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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