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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 Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/21/2019
Event Type  malfunction  
Event Description
It was reported that the catheter broke.The target lesion was located in the superficial femoral artery.A 2.50mm peripheral rotalink plus was selected for use.During withdrawal, it was noted that the catheter broke in half as it was separated in the mid-section.The catheter was then completely removed from the patient's body by normal pin pulled out method including the wire.The procedure was completed using this device.No patient complications were reported and had a good result.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically examined.Inspection of the device revealed that the sheath and coil were detached.There was blood present inside the distal portion of the detached sheath.The sheath was detached 49cm and the coil was detached 44cm distal of the strain relief.The separated ends of coil and sheath were microscopically examined, and it was found that they were a clean break, which is consistent to damage that is similar to the coil being cut.The coil was also microscopically inspected and found to be stretched 1cm proximal of the separation and.25cm distal of the separation, indicating there was force applied to the coil.There were numerous kinks in the sheath and the coil was kinked 3cm proximal of the burr.Functional testing was performed by rotating the drive shaft (handshake connection), and the device was able to rotate with no issues.This confirms there was no issues with the advancer and that the blood in the distal portion of the sheath was due to the device being in the patient when separated.With a test device, it was put in a toughy and pulled with force to try and break the sheath and coil.The sheath and coil did not break but the sheath necked down and the coil stretched, not matching the returned device.The coil and sheath of a test device were than cut with a wire cutter and surgical scissors.The separated ends from the wire cutter did not match the returned complaint device; however, the separated ends cuts with the surgical scissors were comparable to the complaint device.Therefore, with being able to recreate the clean separated ends of the coil and sheath and after all the testing and review of the complaint device, it was determined that the received sheath and coil were cut.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that the catheter broke.The target lesion was located in the superficial femoral artery.A 2.50mm peripheral rotalink plus was selected for use.During withdrawal, it was noted that the catheter broke in half as it was separated in the mid-section.The catheter was then completely removed from the patient's body by normal pin pulled out method including the wire.The procedure was completed using this device.No patient complications were reported and had a good result.
 
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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
MDR Report Key9311549
MDR Text Key171991595
Report Number2134265-2019-13644
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729838968
UDI-Public08714729838968
Combination Product (y/n)N
PMA/PMN Number
K121774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/16/2021
Device Model Number29720
Device Catalogue Number29720
Device Lot Number0023964307
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2019
Date Manufacturer Received11/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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