MAUDE Adverse Event Report: COOK VANDERGRIFT INC. COOK SHORTIE SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Device Problems Calcified (1077); Material Disintegration (1177); Entrapment of Device (1212); Physical Resistance/Sticking (4012)

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

Event Type  Injury  

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 svc and theinnominate vein.Laser was tried but unable to pass this junction.The procedure was abandoned because pt'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 (b)(2).

• Brand Name: COOK SHORTIE SHEATH
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VANDERGRIFT INC.
• MDR Report Key: 17335777
• MDR Text Key: 319255733
• Report Number: MW5119500
• 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: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1