MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	29720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke off.The target lesion was located in the posterior tibial artery.A 1.25mm peripheral rotalink plus was selected for use.During procedure, imaging was performed using an opticross 18 but the ultrasound image was lost and everything went black upon usage.It was also reported that the shaft of the rotalink plus broke off.Everything was removed from the patient's body.The procedure was stopped once everything was out of the patient.No complications reported and patient is fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically and visually examined.The advancer handshake connection and burr catheter handshake connections were both broken.The coil was stretched and separated 10.5cm from the burr tip.The separated coil and burr were returned on the rotawire 11680251; the rotawire could not be removed due to the severe stretching of the coil.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate.Product analysis verified that the device had a melted ultem.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.
Event or Problem Description
It was reported that the device broke off.The target lesion was located in the posterior tibial artery.A 1.25mm peripheral rotalink plus was selected for use.During procedure, imaging was performed using an opticross 18 but the ultrasound image was lost and everything went black upong usage.It was also reported that the shaft of the rotalink plus broke off.Everything was removed from the patient's body.The procedure was stopped once everything was out of the patient.No complications reported and patient is fine.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9261497
• Report Number: 2134265-2019-13197
• Device Sequence Number: 2055248
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0024041053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMAGING CATHETER- OPTICROSS 18; IMAGING CATHETER- OPTICROSS 18
• Patient Age: 62 YR