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

Catalog Number PT-65509

Device Problem Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The tip broke off in the patient and was retrieved with a balloon and another trerotola.The reported defect was detected during use.There was no patient injury/consequence.Patient condition is reported as "fine".Therapy was reported to be delayed/interrupted.

Event Description

The tip broke off in the patient and was retrieved with a balloon and another trerotola.The reported defect was detected during use.There was no patient injury/consequence.Patient condition is reported as "fine".Therapy was reported to be delayed/interrupted.

Manufacturer Narrative

(b)(4).The customer returned one 5fr ptd catheter and lidstock for evaluation.Visual examination revealed the pebax tip was fully 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 jagged and uneven, indicating a stress related tear.The separated pebax tip was severely distorted, twisted, and deformed.All the basket wires were intact and secured within the basket connectors.The ptd basket was able to advance and retract from the sheath with minimal resistance.The ptd catheter was placed into a lab inventory rotator to functionally test, and it was able to rotate.No functional issues were found.A device history record review was completed, and no relevant findings were identified.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 returned.The sample passed all relevant functional testing and a device history record review was performed with no relevant findings.A capa was opened to further investigate this issue.The capa root cause determined to be manufacturing - molding.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET
• Type of Device: CATHETER EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10493584
• MDR Text Key: 206340428
• Report Number: 9680794-2020-00356
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K011056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

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
• Device Operator: No Information
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F20E0204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention