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

Model Number	29720
Medical Device Problem Codes	Contamination (1120); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device contamination occurred.A 1.50mm peripheral rotalink plus was selected for use.Upon receipt of the product, it was noted that there was a puncture to the box and it compromised the sterility of the device.There was no patient involvement.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device found that the outer and inner pouch appeared to be punctured.During review of the returned device, the manufacturing quality team was consulted and provided an explanation of the process requirements and inspection steps in place for the purpose of identifying damages of this nature.It was considered unlikely that the identified damages to the pouch occurred during manufacturing of the device.
Event or Problem Description
It was reported that a device contamination occurred.A 1.50mm peripheral rotalink plus was selected for use.Upon receipt of the product, it was noted that there was a puncture to the box and it compromised the sterility of the device.There was no patient involvement.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14833564
• Report Number: 2134265-2022-07297
• Device Sequence Number: 11960688
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 02/11/2024
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0028856764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown