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

Model Number	29720
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr was stuck in the lesion.The target lesion was located in the right anterior tibial artery.A 1.75mm peripheral rotalink plus and rotawire were selected for use.During the procedure, it was noted that the burr was stuck in the vessel.However, the burr and the wire were retrieved by accessing from a pedal pushing the burr with a micro catheter while simultaneously retrograding at the same time.Subsequently, the burr and the wire were removed intact.The procedure was completed using balloon angioplasty with no new rota was used.Patient was not injured and no complications reported.Patient was fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The returned complaint device consisted of a peripheral rotalink plus device.The burr catheter was received attached to the advancer unit with the returned rotawire in the device.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically and visually examined.There is blood in the drip line and the sheath showing that there was a lack of saline flush.There are numerous sheath kinks.The coil is stretched.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate.Product analysis confirmed the reported event due to the 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 burr was stuck in the lesion.The target lesion was located in the right anterior tibial artery.A 1.75mm peripheral rotalink plus and rotawire were selected for use.During the procedure, it was noted that the burr was stuck in the vessel.However, the burr and the wire were retrieved by accessing from a pedal pushing the burr with a micro catheter while simultaneously retrograding at the same time.Subsequently, the burr and the wire were removed intact.The procedure was completed using balloon angioplasty with no new rota was used.Patient was not injured and no complications reported.Patient was 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: 8596028
• Report Number: 2134265-2019-04984
• Device Sequence Number: 2345645
• Product Code: MCW
• UDI-Device Identifier: 08714729838913
• UDI-Public: 08714729838913
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0023436414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR