MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY FLEXTOME® CUTTING BALLOON®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H749CBM3300100

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

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was hair in the device packaging.A 10/3.00 flextome® cutting balloon® was selected for use.During unpacking, hair was noted in the package on the hoop.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was returned for evaluation.The carton had been opened prior to receipt at the investigation site containing the unused device that was still in the carrier tube.The pouch was not returned.The foreign matter (fm) was present on the carrier tube as described in the event description.The fm was microscopically examined and was confirmed to be a hair follicle due to the presence of root at the base of the follicle.The follicle measured 55mm in length.As the pouch had already been opened prior to receipt at the investigation site, it cannot be determined where the hair follicle originated from, however the production unit that manufactured and packaged the device were made aware of the issue.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that there was hair in the device packaging.A 10/3.00 flextome® cutting balloon® was selected for use.During unpacking, hair was noted in the package on the hoop.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5976106
• MDR Text Key: 55565889
• Report Number: 2134265-2016-08507
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2016

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: 07/05/2019
• Device Model Number: H749CBM3300100
• Device Catalogue Number: CBM330010
• Device Lot Number: 19445321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• 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