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

Catalog Number 400SMTXSFT2H03

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a coil embolization procedure, the physician attempted to flush the penumbra smart coil (smart coil) within its introducer sheath; however, the fluid was not dripping out of the end of the introducer sheath.Therefore, the smart coil was not used in the procedure.The penumbra smart coil detachment handle was not used because the smart coil was never inserted into the patient.The procedure was completed using a new coil.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly.Bends and kinks were present on the pusher assembly approximately 11.5, 31.0, 49.0 and 99.0 cm from the proximal end.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).The embolization coil was undamaged.Th introducer sheath was ovalized approximately 24.0, 40.0, 45.5 and 59.0 cm from the proximal end.Conclusions: evaluation of the returned smart coil revealed a device that was capable of being flushed.During functional testing, the introducer sheath was flushed with liquid, and the liquid was able to be flushed through the entire introducer sheath.The reported complaint could not be confirmed.Further evaluation revealed pusher assembly kinks and ovalizations along the introducer sheath.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.H3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8569377
• MDR Text Key: 143708565
• Report Number: 3005168196-2019-00840
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015316
• UDI-Public: 00814548015316
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• 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: 01/01/2005,04/02/2019

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: Health Professional
• Device Expiration Date: 06/07/2023
• Device Catalogue Number: 400SMTXSFT2H03
• Device Lot Number: F83935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 07/26/2019
• Supplement Dates FDA Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1