MAUDE Adverse Event Report: PENUMBRA, INC. POD6; HCG, KRD

Catalog Number RBYPOD6

Device Problems Physical Resistance (2578); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-01302.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery (spa)/ common hepatic artery (cha) using pod6s and a penumbra coil 400 (pc400).During the procedure, while attempting to insert a pod6 into the hub of a non-penumbra microcatheter, the physician experienced resistance at the distal tip of the pod6 introducer sheath; therefore, the physician removed the pod6 and soaked it in a saline tray.The physician then attempted again to advance the pod6 into the hub of the microcatheter; however, the pod6 became stuck at the same position in its introducer sheath.Therefore, it was removed.While attempting to advance a pc400 through the microcatheter, the pc400 pusher became kinked and subsequently, the pc400 unintentionally detached in the microcatheter.It was reported that the proximal end of the pc400 was approximately five centimeters into the microcatheter.Therefore, the physician removed the microcatheter containing the pc400 pusher assembly, the detached coil and removed the coil.The procedure was completed using the same microcatheter, four pod coils, one penumbra smart coil (smart coil) and four others coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 117.0 and 118.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The distal tip of the embolization coil was advanced outside of the distal tip of the introducer sheath and the sheath had coagulated blood inside.Conclusion: evaluation of the returned pod6 revealed that the pusher assembly was kinked.If the device is forcefully advanced against resistance, damage such as a kink may occur.During the functional test, resistance was encountered while attempting to retract the kinked pusher assembly through its introducer sheath due to the pusher assembly kinks and the pod6 could not be retracted any further.Further evaluation of the returned pod6 revealed that the introducer sheath had coagulated blood inside.This typically occurs if continuous flush is not used during the procedure.The kink in the pusher assembly and the coagulated blood inside the introducer sheath prevented the pod6 from being functionally tested during evaluation.Evaluation of the returned pc400 revealed that the pusher assembly was fractured.If the device is forcefully advanced against resistance, damage such as a kink may occur.Subsequently, if the kinked device is further manipulated the device may become fractured.Further evaluation of the returned pc400 revealed that the embolization coil was detached from its pusher assembly.If the two fractured segments of the pusher assembly are separated the pull wire will likely retract out of the ddt, detaching the embolization coil.Evaluation of the non-penumbra microcatheter revealed that the device was kinked in multiple locations.A demonstration coil was attempted to be advanced through the microcatheter; however, resistance was encountered and the coil could not be advanced any further.The complaint states that the same microcatheter was used to complete the procedure indicating these damages likely occurred post procedure.Penumbra coils 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: 3005168196-2018-01302.

• Brand Name: POD6
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7651782
• MDR Text Key: 112845388
• Report Number: 3005168196-2018-01301
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013817
• UDI-Public: 00814548013817
• Combination Product (y/n): Y
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPOD6
• Device Lot Number: F72342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• 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: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR