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

Model Number	29720
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.The returned complaint device consisted of a peripheral rotalink plus device.The device was received attached to the advancer unit.Blood was noted in the advancer.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically and visually examined and numerous sheath kinks were noted.In addition, the sheath was completely torn at 85.4cm and 97.2cm from the strain relief.Microscopic examination of the device observed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The coil was also noted to be stretched.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate and melted ultem was noted.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 27-jun-2019.It was reported that the rotational speed not able to stabilize during preparation for use.The 75% stenosed target lesion was located in a moderately tortuous and severely calcified anterior tibial artery.A 1.25mm peripheral rotalink plus catheter was selected for use.During preparation outside the patient's body, the rotational speed was set to 180,000 rpm; however, it was noted that the rotational speed went from 150,000 to 250,000 rpm.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis noted that the sheath was torn.

• 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: 8808092
• Report Number: 2134265-2019-08493
• Device Sequence Number: 457502
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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: 04/18/2020
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0022012785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/19/2019
• Patient Sequence Number: 1
• Patient Weight: 53