MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number 3MAXC

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the 3maxc was ovalized approximately 100.0 cm from the hub.Unraveled metal wire was protruding from the hub.Bends were present along the length of the device.Conclusions: evaluation of the returned psr3d revealed an undamaged device.No visible damage was observed on the psr3d and it was able to be advanced through a demonstration catheter without issue.The reported complaint could not be confirmed.Evaluation of the returned 3maxc revealed coil winds unraveled and protruding from its hub.If the catheter liner becomes compromised, the psr3d may interact with the coil winds upon retraction.The coil winds were stuck on the distal end of the psr3d.The subsequent retraction of the psr3d likely resulted in the unraveling of the 3maxc inner coil winds.Bends were present along the length of the 3maxc and the psr3d delivery wire.Based on the returned condition and the reported complaint, the bends are likely incident reported complaint and may have occurred during packaging for return to penumbra.Penumbra catheters and revascularization devices 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 thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d) and a penumbra system 3max reperfusion catheter (3maxc).During the procedure, the psr3d broke apart and stretched when advanced only slightly into the 3maxc during the first pass and, therefore, the 3maxc was removed with the psr3d inside.The procedure was completed using a new psr3d and a new 3maxc.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Type of Device: NRY
• 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: 7878844
• MDR Text Key: 120394294
• Report Number: 3005168196-2018-01821
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019932
• UDI-Public: 00814548019932
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160449
• 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: 01/01/2005,08/17/2018

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: 06/11/2021
• Device Catalogue Number: 3MAXC
• Device Lot Number: F83983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Is the Reporter a Health Professional?: Yes
• 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: 08/17/2018
• Initial Date FDA Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2018
• 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 Age: 95 YR
• Patient Weight: 54