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

Catalog Number PT-65509

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The doctor was performing a declot procedure on a patient with a graft in the arm.The tip broke off in the graft of the patient.They were able to retrieve the tip but had to place a stent in the graft due to some damage.Nurse follow-up states patient is doing well.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 doctor was performing a declot procedure on a patient with a graft in the arm.The tip broke off in the graft of the patient.They were able to retrieve the tip but had to place a stent in the graft due to some damage.Nurse follow-up states patient is doing well.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

Qn#(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 and not returned for evaluation.Microscopic examination confirmed the basket wires were fully welded.The returned ptd basket was able to be retracted and advanced from the ptd catheter.The returned ptd catheter was assembled with a lab inventory rotator.When the rotator button was depressed, the ptd catheter performed as expected.A device history record review was performed with no relevant findings.The instructions-for-use provided with this kit warns the user, "potential fatigue failure of ptd torque cable and fragmentation basket may occur with prolonged activation of ptd device.When using the ptd within the apex of a forearm loop graft, limit operation to 3 minutes or less to reduce the potential for basket failure.A rapid withdrawal rate of 1-2 cm/second is recommended when sharp radii are encountered (i.E., radius of loop graft, radii 3 cm)." the customer report of a separated ptd tip was confirmed by complaint investigation of the returned sample.The ptd pebax tip was completely separated from the basket and was not returned for evaluation.A device history record review was performed with no relevant findings.A capa has previously been initiated to further investigate this issue.The root cause has been determined as a manufacturing (molding) issue.Corrective actions have not yet been implemented.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET
• Type of Device: CATHETER EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10437701
• MDR Text Key: 203879539
• Report Number: 9680794-2020-00347
• 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: 08/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F20D0122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention