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

Model Number H802228240022

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2017

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 the device sterile packaging was opened.A 330cm rotawire¿ was selected for use.During unpacking, it was noted that the packaging was already opened and the rotawire became unsterile.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the rotawire was returned inside the hoop, with its pouch.The bottom end of the received pouch was completely opened and did not have evidence of the sealed marks.The other three sides of the pouch look normal, the seals were in good condition.The measurement of the pouch was within specification.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 the device sterile packaging was opened.A 330cm rotawire¿ was selected for use.During unpacking, it was noted that the packaging was already opened and the rotawire became unsterile.The procedure was completed with another of the same device.There were no patient complications reported.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6913292
• MDR Text Key: 88114398
• Report Number: 2134265-2017-09674
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

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: 12/03/2017
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 18700953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 10/04/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2015
• 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