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 12/08/2015

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

Same case as: 2134265-2015-09354.It was reported that foreign material was noted.A rotawire was selected to treat an unspecified target lesion.It was noted that there was a white substance on the rotawire that the physician attempted to wipe off.The substance then turned powdery.The physician elected to load a rotaburr on the wire and noticed that more of the substance appeared to be coming off.The physician removed the burr, cleaned the system and attempted to advance the same burr over a new rotawire; however, the same issue occurred.The procedure was completed with the same burr and another of the same rotawire.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that when the rota burr was being advanced over the rotawire, "it would almost scrapped a residue".They cut the tip of the wire and removed it.They opened the second wire from the same lot number and box and used it with the same burr and had no problem.

Manufacturer Narrative

Device evaluated by mfr.: device evaluated by mfr.: the device was returned for evaluation.The device was inspected and no evidence of foreign matter was noted.Visual inspection noted that the wire was broken by tension overload near to the distal section 326 cm from the proximal section.Also, it was observed that the distal tip was not returned and the wire was kinked in the middle of the device.Overall length and outer diameter (od) of the distal tip was not measured due to the device condition; however, the rest of the od were within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was further reported that when the rota burr was being advanced over the rotawire, "it would almost scrapped a residue".They cut the tip of the wire and removed it.They opened the second wire from the same lot number and box and used it with the same burr and had no problem.

• 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: 5352008
• MDR Text Key: 35299373
• Report Number: 2134265-2015-09415
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• 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,Followup
• Report Date: 12/16/2015

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: 05/31/2017
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 18047037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/04/2016; 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2015
• 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