MAUDE Adverse Event Report: COOK INC; DYB INTRODUCER, CATHETER

Catalog Number UNKNOWN

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an unknown procedure, an unspecified cook flexor sheath separated.The procedure was reportedly difficult and the sheath was difficult to remove from the patient; however, the entire sheath was removed successfully.Per the user facility, the physician has retired and additional information will not be provided.

Manufacturer Narrative

Description of event: as reported, during an unknown procedure, an unspecified cook flexor sheath separated.The procedure was reportedly difficult and the sheath was difficult to remove from the patient; however, the entire sheath was removed successfully.Investigation ¿ evaluation.A document based investigation was performed including a review of manufacturing instructions and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Based on the provided evidence and the completed investigation, cook has concluded a definitive conclusion could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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

No new patient or event information to report.

• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11010751
• MDR Text Key: 223830117
• Report Number: 1820334-2020-02298
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1