MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5; CATHETER EMBOLECTOMY

Model Number	IPN035902
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
The complaint is reported as: trying to perform a declot and the ptd tip broke going through the sheath and got lodged in the fistula.Tried to snare and was unsuccessful.A covered stent was placed to prevent migration of the tip.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one 5fr ptd catheter, rotator, and product lidstock for evaluation.Signs-of-use in the form of biological material was observed on the catheter.Visual examination revealed the pebax tip was separated from the ptd basket.Microscopic examination confirmed that the black pebax tip broke near the base of the distal basket.The tip material appeared folded and uneven, indicating a stress related tear.The separated pebax tip was not returned.All the basket wires were intact and secured within the basket connectors.The total length of the pebax tip measured to be 0.10" which indicates at least 0.4156" were separated and not returned per product drawing.The sample was functionally tested in accordance with the instructions-for-use, "unlock and slide side arm from slot no.1 to slot no.2.Lock into place.The outer cover catheter will be retracted to expose the basket.This is the deployed position used to treat thrombus in graft/fistula.Depress on/off switch to ensure that fragmentation basket spins freely.Release switch to stop motor.If any part of system fails to work properly, replace component and retest." the ptd basket was able to advance and retract from the sheath with minimal resistance.The ptd catheter was placed into the returned rotator to functionally test, and it was able to rotate.No functional issues were found.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with the kit warns the user, "the ptd device is not for use in stents." it also instructs the user, "if the flexible tip "folds over" itself when it encounters the sheath valve, insert the folded-over tip through the valve and pull back slightly to allow tip to unfold in open cavity of the hub.At this point, the device can be fed through the sheath into the graft." the ifu warns, "keep exposed portion of ptd catheter straight at all times to aid in successful basket deployment.Potential fatigue failure of the ptd torque cable and fragmentation basket may occur with prolonged activation of ptd device.The cumulative activation time of the ptd device in all radii should be limited to 30-60 seconds.A rapid withdrawal rate of 1-2 cm/second is recommended when sharp radii are encountered (i.E.Radius of loop graft or vessel, radii < 3 cm).Do not advance ptd catheter forward during activation." the customer report of a separated ptd basket tip was confirmed by complaint investigation of the returned sample.A portion of the black pebax tip was separated and not returned.The sample passed all relevant functional testing.A device history record review was performed with no relevant findings.Further investigation of this issue will be conducted under a capa.The capa root cause has been determined to be manufacturing (molding).Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
The complaint is reported as: trying to perform a declot and the ptd tip broke going through the sheath and got lodged in the fistula.Tried to snare and was unsuccessful.A covered stent was placed to prevent migration of the tip.The patient's condition is reported as fine.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5
• Common Device Name: CATHETER EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11544140
• Report Number: 9680794-2021-00125
• Device Sequence Number: 17277522
• Product Code: DXE
• UDI-Device Identifier: 00801902013156
• UDI-Public: 00801902013156
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K011056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: No Information
• Device Expiration Date: 09/30/2022
• Device Model Number: IPN035902
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F20K0631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 03/27/2021
• 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