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

Catalog Number RBYPODJ45

Device Problems Bent (1059); Detachment Of Device Component (1104); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

Results: blood was observed inside the pusher assembly lumen and on the embolization coil.The pet lock was intact on the proximal end of the first podj coil pusher assembly.The pusher assembly was fractured approximately 5.0 cm from the proximal end and kinked in multiple locations.The embolization coil was detached from the pusher assembly and unraveled, and the stretch resistant wire (sr wire) was fractured.Conclusions: evaluation of the first podj coil revealed blood was present in the pusher assembly lumen and on the embolization coil.Since the original complaint reported that the first podj coil became unintentional detached during removal from the packaging on the back table, the root cause of this complaint could not be determined.Further evaluation revealed the embolization coil was detached and unraveled and the sr wire was fractured.Fracture of the sr wire typically occurs due to forceful retraction of the podj coil against resistance, and will allow the embolization coil to detach and unravel.Evaluation of the second podj coil revealed the pet lock was intact, the embolization coil was detached and had the proximal constraint sphere intact, and blood occluded the ddt.The id of the ddt and the od of the pull wire could not be measured due to the dried blood in the ddt.The lantern kicking back may have contributed to the unintentional detachment of the second podj coil.Evaluation of the both podj coil pusher assemblies revealed both were kinked, and the first podj coil¿s pusher assembly was fractured.This damage was likely incidental and may have occurred during packaging for return.Evaluation of the returned device revealed the lantern was kinked.This damage may have occurred when the lantern kicked out of the aneurysm.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 numbers: 3005168196-2017-00834, 3005168196-2017-00835.

Event Description

The patient was undergoing a coil embolization in the splenic artery using pod packing coils (podj coils) and a lantern delivery microcatheter (lantern).During the procedure, prior to use, the physician inadvertently bent a podj coil pusher assembly while removing the podj coil from its dispenser hoop.Consequently, the podj coil unintentionally detached on the back table.Therefore, the podj coil was set aside and a new podj coil was opened to continue the procedure.While advancing the new podj coil through the lantern, the physician experienced resistance causing the lantern to kick back into the non-penumbra base catheter.Thus, the podj coil was pulled into the base catheter as well.Upon retraction, the podj coil unintentionally detached within the base catheter.Therefore, the physician removed the base catheter and the lantern containing the detached coil from the patient.The procedure was completed using a new base catheter, lantern and two additional podj coils.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: 6605296
• MDR Text Key: 76440276
• Report Number: 3005168196-2017-00833
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141134
• 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: 05/02/2017

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: Physician
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F72020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• 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