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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 29720
Device Problems Contamination (1120); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/06/2022
Event Type  malfunction  
Event 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.
 
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 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.
 
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Brand Name
PERIPHERAL ROTALINK PLUS
Type of Device
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 Key14833564
MDR Text Key301834055
Report Number2134265-2022-07297
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729838906
UDI-Public08714729838906
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/11/2024
Device Model Number29720
Device Catalogue Number29720
Device Lot Number0028856764
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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