MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION

Catalog Number LR-EVN-SH-11.0-RL

Device Problems Calcified (1077); Material Disintegration (1177); Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problems Low Blood Pressure/ Hypotension (1914); Foreign Body In Patient (2687)

Event Date 07/26/2023

Event Type  Injury  

Manufacturer Narrative

Fill in the common name/product code/510k information if needed, ¿this report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.¿ the event is currently under investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Cook shortie sheath were alternately used but significant calcification was encountered at the subclavian junction.It could not be advanced past the innominate vein, so it was replaced with a tightrail, dilating sheath.Alternating between this and a cook evolution sheath, the surgeon was able to close to the superior vena cava and the innominate vein.Laser was tried but unable to pass this junction.The procedure was abandoned because patient's blood pressure dropped, requiring medication.When the sheath was removed, it was found that the leads had started to break apart.The lead remnants were capped.This report reflects information received by fda in the form of a notification per 803.22.

Event Description

Cook shortie sheath were alternately used but significant calcification was encountered at the subclavian junction.It could not be advanced past the innominate vein, so it was replaced with a tightrail, dilating sheath.Alternating between this and a cook evolution sheath, the surgeon was able to close to the superior vena cava and the innominate vein.Laser was tried but unable to pass this junction.The procedure was abandoned because patient's blood pressure dropped, requiring medication.When the sheath was removed, it was found that the leads had started to break apart.The lead remnants were capped.This report reflects information received by fda in the form of a notification per 803.22.

Manufacturer Narrative

G5 ¿ pma/510(k): k141148.The device was not returned for the complaint, therefore a physical investigation could not be performed and the customer's complaint could not be confirmed, other than by the customer's testimony.The complaint/event that was entered and reported within trackwise: "when the sheath was removed it was noticed that the leads had started to break apart." the device history record (dhr) was unable to be viewed due to the lot number specific to this complaint was unknown.This complaint mode is being monitored, tracked and trended per the cvi post market surveillance and complaint handling processes.A risk assessment will be performed and documented in the complaint summary tab in trackwise.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Type of Device: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: timothy vogel ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 17583676
• MDR Text Key: 322376472
• Report Number: 2522007-2023-00014
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LR-EVN-SH-11.0-RL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: G31923/LR-TSS-SH-11.0; LASER; LASER; LR-TSS-SH-11.0; PHILIPS TIGHTRAIL DILATING SHEATH; TIGHTRAIL DILATING SHEATH PHILIPS
• Patient Outcome(s): Other; Required Intervention