MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number 4006C0406

Device Problems Retraction Problem (1536); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly and had offset winds.The introducer sheath had coagulated blood inside.The embolization coil was advanced out of its introducer sheath.Conclusions: evaluation of the returned device revealed that the penumbra coil 400 (pc400) embolization had offset coil winds.This type of damage typically occurs due to improper handling during use.If the device forcefully advanced against resistance, damage such as this may occur.Further evaluation of the returned device revealed that the introducer sheath had coagulated blood inside and part of the embolization coil was advanced out of its introducer sheath.If continuous flush is not used, blood is more likely to coagulate on the embolization coil and inside the introducer sheath, which may contribute to difficulty when re-sheathing.The root cause of the initial reported resistance could not be determined.The px slim delivery microcatheter (px slim) mentioned in the complaint was not returned for evaluation.Penumbra coils 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.

Event Description

The patient was undergoing a coil embolization procedure in the right inferior gluteal artery using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed a pc400 using a px slim delivery microcatheter (px slim).The physician then felt resistance and was unable to advance a second pc400 more than halfway through the px slim.The physician therefore removed and attempted to re-sheathe the pc400, however was unable to retract it into the introducer sheath.The procedure was then completed using the same px slim, additional pc400s, and additional coils.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• 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: 7151162
• MDR Text Key: 96025248
• Report Number: 3005168196-2017-02291
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548011899
• UDI-Public: 00814548011899
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 4006C0406
• Device Lot Number: F33956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2013
• 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 Age: 83 YR