MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ROTAWIRE¿ AND WIRECLIP¿ TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number H802228240022

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

Patient Problem No Patient Involvement (2645)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that foreign material was noted.A rotawire¿ and wireclip¿ torquer was selected for use.During unpacking, it was noted that the wire was contaminated with hair.The physician decided to return the device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation on a sealed pouch.Device analysis noted a hair strand inside the package.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause has been determined to be manufacturing related.(b)(4).

Event Description

It was reported that foreign material was noted.A rotawire¿ and wireclip¿ torquer was selected for use.During unpacking, it was noted that the wire was contaminated with hair.The physician decided to return the device.No patient complications were reported and the patient's status was good.

• Brand Name: ROTAWIRE¿ AND WIRECLIP¿ TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5383633
• MDR Text Key: 36550087
• Report Number: 2134265-2016-00038
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

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: 08/12/2017
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 18294098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2015
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2015
• 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