MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TWIN-PASS; DUEL ACCESS CATHETER

Model Number 5200

Device Problem Separation Problem (4043)

Patient Problem Death (1802)

Event Date 04/24/2019

Event Type  Death  

Manufacturer Narrative

Twin-pass device was returned for evaluation.The manufacturing records were reviewed and no nonconformances related to this lot were found, therefore supporting the device met material, assembly and performance specifications prior to shipment.The complaint was confirmed, the distal tip of the device was separated.The proximal side of the otw port to the separation point measured 5mm suggesting that 2-2.5 cm of tip was missing.The pebax material at the separation point was stretched signifying the catheter was pulled against resistance.The distal most section shows that all three construct layers were present.The rx lumen of the catheter was split longitudinally from distal to proximal.

Event Description

Per medwatch uf/ im report (b)(4).The tip of the dual-pass catheter broke off during cardiac intervention and has migrated into the patient's ramus.It could not be retrieved using a snare and the patient is too sick for surgical removal.Additional information received 25apr2019: during emergent case, twin-pass was advanced down the ramus vessel over guidewire, and a second guidewire was advanced to access the lad.Upon removal of the twin-pass, the tip was sheared off and was in the left main artery.Snaring with the micro-elite snare was unsuccessful, and the tip migrated distally down the ramus.Physician notes stated that there was no flow limitation.Supplementary information received per the physician, the patient did pass away.The cod (cause of death) was reported as ischemic cardiomyopathy.

• Brand Name: TWIN-PASS
• Type of Device: DUEL ACCESS CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 8631869
• MDR Text Key: 145777818
• Report Number: 2134812-2019-00037
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083784
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2019
• Device Model Number: 5200
• Device Lot Number: 607728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2017
• 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 Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 55