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

Catalog Number RBYPODJ30

Device Problems Detachment Of Device Component (1104); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pull wire was completely retracted out of the distal detachment tip (ddt) embolization coil was detached from its pusher assembly.The embolization coil with the constraint sphere intact was stuck on the distal end of the non-penumbra snare.Conclusions: evaluation of the podj revealed that the pull wire was completely retracted out of the ddt and the embolization coil was detached from its pusher assembly.If the pull wire is retracted out of the ddt, the embolization coil will detach from its pusher assembly.The pet lock on the proximal end of the pusher assembly was damaged, but not broken.The root cause of the pull wire being retracting out of the ddt could not be determined.The complaint further stated that the embolization coil was bunching up inside the hub of the lantern.If the introducer sheath is not properly aligned within the hub of the lantern, damage such as the embolization coil bunching up inside the hub of the catheter may occur.The lantern identified in the complaint was not returned to penumbra for evaluation.Penumbra coils and catheters are visually 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: 3005168196-2018-01234.

Event Description

The patient was undergoing a coil embolization procedure using pod packing coils (podjs).During the procedure, the physician successfully deployed and detached four podjs using a lantern delivery microcatheter (lantern).The physician then attempted to place another podj, however, experienced resistance while advancing the podj was partially within the lantern.It was reported that the podj was bunching up at the hub of the lantern.The physician therefore removed the podj and retracted the podj back into its introducer sheath on the back table.The physician then re-inserted the same podj into the patient; however, as the physician was advancing the podj into the target location the podj unintentionally detached.The physician was able to remove the detached podj by using a snare device and the procedure was completed using a new lantern and two additional podjs.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7620714
• MDR Text Key: 111741786
• Report Number: 3005168196-2018-01233
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 00814548017655
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2018

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: Physician
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F82372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR