MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET; VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION

Catalog Number LR-EVN-13.0-RL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 10/10/2018

Event Type  Death  

Manufacturer Narrative

Product code: dre.Pma/510(k): k141148.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

Initial rr 76/48, 9:40 start, 9:50 device explant 10:15 rv1 lld ez, 10:18 rv2 lld ez, 10:20 rv2 glidelight 14 easy work to atrium then no progression, 10:25 rv1 glidelight 14 easy work to high svc then no progression, 10:30 rv1 evn 13 rl n155274 easy work to apex then 1 cm before tip no progression, 10:33 vf 2x 360 j defib no pressure reanimation =>adrenalin rr 103/48, 10:38 rv2 evn 13 rl easy work to apex, 10:40 rv2 extracted in toto, 10:41 current blackout of anesthesia monitors => tee machine restarted, 10:45 rr 42/3, 10:54 hlm started to stabilizing patient, 11:00 reanimation, 11:12 echo pleura effusion => thoracotomies, 11:15 hlm running, 11:20 4 cm high svc superior cut closed with patch, 11:30 3 cm cut at v.Anonima closed with patch, 11:27 patient stabilized, 12:28 low flow via svc due to surgical lumen reduction with patch, 12:45 volumen refilling with cellsaver and ecmo.Only 0,6 - 1,2 l volume filling possible, due to closed svc.Refilling with t adapter and via v.Pulmonale, v.Femoral and svc without bigger success, 13:30 decision to stop the pump => exitus.

Manufacturer Narrative

Pma/510(k): k141148.Added summary of investigation: investigation summary: the complaint device was not returned for a physical evaluation, therefore a determination if a device malfunction occurred is inconclusive.The instructions for use was reviewed and listed as a potential adverse event is 'laceration or tearing of vascular structures or the myocardium'.This complaint event is a known failure mode and will be monitored and trended via the complaint handling and post market surveillance processes.A risk assessment will be completed per qera/risk assessment for this complaint.A review of the device history record for this lot number was performed including the manufacturing and quality control records.All steps were documented per procedure and by trained personnel.There was no evidence found to indicate the device was manufactured out of specification additionally there were no signs to indicate that a nonconforming device was released to the field.

Event Description

For investigation of this event.

• Brand Name: LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Type of Device: VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer (Section G): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 4128458621
• MDR Report Key: 7966496
• MDR Text Key: 123796985
• Report Number: 2522007-2018-00027
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 10827002237473
• UDI-Public: (01)10827002237473(17)210430(10)N155274
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

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: 04/30/2021
• Device Catalogue Number: LR-EVN-13.0-RL
• Device Lot Number: N155274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 10/10/2018
• Supplement Dates FDA Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2018
• 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 Outcome(s): Death
• Patient Age: 60 YR
• Patient Weight: 54