MAUDE Adverse Event Report: COOK INC FLEXOR SHUTTLE GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	G49481
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Name and address: postal code: (b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a cerebral angioplasty and using a flexor shuttle guiding sheath, the sheath tip was damaged.The reported device was inserted from the right cfa to the abdomen for the procedure.The physician noted resistance when inserting the sheath, so they stopped using it.They checked the device and noticed there was damage on the sheath tip on the outer cannula.The damage was noted to be a split in the tip.Therefore, another of the same type device was used instead.No adverse effects to the patient were reported due to this occurrence.
Event or Problem Description
During evaluation of the device, it was determined that the sheath tip was damaged, but was not split as originally reported.
Additional Manufacturer Narrative
Correction- b5, h1: the complainant returned one used ksaw-6.0-38-80-rb-shtl (flexor shuttle guiding sheath) to cook for investigation.The distal tip of the sheath was confirmed to be damaged; however, the tip was not split as originally reported.Per a search of risk documentation and previous complaint data, there is no evidence to suggest that this device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury was alleged, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.

• Brand Name: FLEXOR SHUTTLE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11935162
• Report Number: 1820334-2021-01457
• Device Sequence Number: 4662393
• Product Code: DYB
• UDI-Device Identifier: 00827002494817
• UDI-Public: (01)00827002494817(17)240408(10)13880072
• Combination Product (Y/N): N
• PMA/510(K) Number: K142819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2024
• Device Model Number: G49481
• Device Catalogue Number: KSAW-6.0-38-80-RB-SHTL
• Device Lot Number: 13880072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1