MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE

Catalog Number CAT6

Device Problems Physical Resistance (2578); Material Deformation (2976); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the indigo system cat6 reperfusion catheter (cat6) was ovalized approximately 26.0, 33.0, and 77.0 cm from the hub.The cat6 was ovalized approximately 126.0 from the hub to the distal tip.Conclusions: evaluation of the device revealed the cat6 tip was severely ovalized.These ovalizations can occur if the peel-away introducer sheath is gripped too tightly when attempting to advance the cat6 into a sheath or a parent catheter.Further investigations revealed more ovalizations along the cat6 catheter shaft.These damages are likely incidental and may have occurred during packaging for return to penumbra facilities.Penumbra 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.

Event Description

The patient was undergoing a thrombectomy procedure in the femoral vein using an indigo system aspiration catheter 6 (cat6).Upon attempting to advance the cat6 peel-away introducer sheath into the access sheath, the physician experienced resistance and the cat6 became stuck within the introducer sheath.The tip of the cat6 had, consequently, become crimped.The physician therefore removed the cat6, and completed the procedure using a new cat6.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• Type of Device: DXE
• 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: 6330590
• MDR Text Key: 67443117
• Report Number: 3005168196-2017-00208
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160533
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/13/2019
• Device Catalogue Number: CAT6
• Device Lot Number: F72053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2016
• 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
• Patient Age: 5 YR