MAUDE Adverse Event Report: PENUMBRA, INC. POD PACKING COIL; HCG, KRD

Model Number RBYPODJ15-A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.(b)(4).This report is associated with mfr report number: 3005168196-2020-01643.

Event Description

The patient was undergoing a coil embolization procedure in the varicocele vein using packing coils (pod pc), lantern delivery microcatheter (lantern), and pod detachment handle (handle).During the procedure, the physician placed a pod pc in the target vessel using a lantern.However, after detaching the pod pc using a handle, the physician noticed the pod pc had punctured the side of the lantern towards the distal end.Therefore, the lantern containing the detached pod pc were removed.The procedure was completed using a non-penumbra catheter and non-penumbra coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pod pc embolization coil was detached form the pusher assembly and had offset coil winds.The pusher assembly was not returned for evaluation.Conclusions: evaluation of the returned pod pc embolization coil confirmed it was detached and had punctured the lumen of the lantern.The embolization coil had offset coil winds along its length and was damaged near the puncture site.If the embolization coil is forceful advanced through a puncture in a catheter, the embolization coil damage will likely result.Evaluation of the returned lantern confirmed a puncture and revealed ovalizations on the distal end of the catheter.The catheter was ovalized an flattened distal to the puncture site.Repeated manipulation in distal patient anatomy may have contributed to this damage.Attempts to advance through this damage region of the catheter would likely result in resistance.Forceful advancement of the catheter against resistance can lead to additional catheter and coil damage.Penumbra coils and catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2020-01643.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10623888
• MDR Text Key: 209697367
• Report Number: 3005168196-2020-01642
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017648
• UDI-Public: 00814548017648
• Combination Product (y/n): Y
• PMA/PMN Number: K170852
• 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: 01/01/2005,09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPODJ15-A
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: F92769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR