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

Model Number H802228240022

Device Problems Peeled/Delaminated (1454); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

It was reported that a mild flaking/peeling of the wire occurred.The target lesion was located in the left anterior descending artery.A 330cm rotawire was selected.While introducing a 1.25mm rotalink burr, while still external to the patient, it was noted that the burr was not advancing smoothly on the wire.A mild flaking/peeling of the rotawire was observed.The rotawire was exchanged for another wire and the procedure was completed.There were no patient complications reported and the patient's status is stable.

Event Description

It was reported that a mild flaking/peeling of the wire occurred.The target lesion was located in the left anterior descending artery.A 330cm rotawire¿ was selected.While introducing a 1.25mm rotalink burr, while still external to the patient, it was noted that the burr was not advancing smoothly on the wire.A mild flaking/peeling of the rotawire was observed.The rotawire was exchanged for another wire and the procedure was completed.There were no patient complications reported and the patient's status is stable.

Manufacturer Narrative

Age at time of event: 18 years and older.(b)(4).

Manufacturer Narrative

Device evaluated by mfr: the device was returned in a generic plastic bag.The visual and tactile inspection was performed and the device presents a white powder along the body.All the outer diameter measurements are within the specifications.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).

• 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 (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3842859
• MDR Text Key: 4613647
• Report Number: 2134265-2014-03216
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2014

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: 11/11/2015
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 16525506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2014
• Initial Date FDA Received: 06/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• 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