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

Model Number	G13091
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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 procedure involving the right leg via contralateral access, a flexor raabe guiding sheath unraveled and separated.The tip of the complaint device was placed in the mid right superficial artery.Advancement of the sheath over the steep bifurcation was reportedly uneventful.During an attempt to exchange the complaint device for a larger sheath, the user pulled the complaint device back, using fluoroscopy.After several centimeters of the sheath was pulled back, resistance was encountered.The user pulled slightly harder and the sheath "snapped" at the bifurcation.Per the reporter, excessive force was not applied prior to the device unraveling and separating.As the proximal portion of the sheath was removed, thin white slivers were noted on the rosen wire that was in place.The patient was sent to the operating room for exposure of the groin and retrieval of the sheath and device debris.Endovascular retrieval was not considered.The patient is reportedly doing fine.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: as reported, during a procedure involving the right leg via contralateral access, a flexor raabe guiding sheath unraveled and separated.The tip of the complaint device was placed in the mid right superficial artery.Advancement of the sheath over the steep bifurcation was reportedly uneventful.During an attempt to exchange the complaint device for a larger sheath, the user pulled the complaint device back, using fluoroscopy.After several centimeters of the sheath was pulled back, resistance was encountered.The user pulled slightly harder and the sheath "snapped" at the bifurcation.Per the reporter, excessive force was not applied prior to the device unraveling and separating.As the proximal portion of the sheath was removed, thin white slivers were noted on the rosen wire that was in place.The patient was sent to the operating room for exposure of the groin and retrieval of the sheath and device debris.Endovascular retrieval was not considered.The patient is reportedly doing fine.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.The customer returned the device to cook for investigation.Physical examination of the returned device showed: one used, damaged device was received.No hub was present.The inside coil was wrapped around a wire guide.The coil was stretched and elongated.Small pieces of the inner liner were noted.There is no evidence from device failure analysis that the complaint was manufactured out of specification.A review of the device history record (dhr) found 1 non-conformance related to the reported failure mode.Cook concluded that the 1 non-conformance were not related to this incident.A database search for complaints on the reported lot found no additional complaints reported from the field.At this time, cook concluded that no nonconforming product from this lot exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "warnings¿: ¿if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal.¿ ¿reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ ¿precautions¿: ¿in order to ensure device compatibility, choose a sheath size large enough to accommodate the maximum outer diameter of any devices that will be placed through the sheath.¿ ¿all interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage.¿ ¿sheath removal¿: ¿insert a wire guide until its tip extends at least 10cm past the tip of the sheath.¿ ¿remove the sheath.Avoid applying traction to the hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit.¿ ¿remove the wire guide.¿ 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.Cook has concluded with current, limited information, the cause for this event can likely be traced to the patient¿s anatomy and user/procedural issues.The complaint was confirmed based on customer testimony and examination of the returned device.There is no evidence that the device was manufactured out of specification.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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 or Problem Description
No new patient or event information since the last report was submitted.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11999022
• Report Number: 1820334-2021-01508
• Device Sequence Number: 3589396
• Product Code: DYB
• UDI-Device Identifier: 00827002130913
• UDI-Public: (01)00827002130913(17)230424(10)13155316
• Combination Product (Y/N): N
• Initial Reporter Country: IC
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2023
• Device Model Number: G13091
• Device Catalogue Number: KCFW-5.0-38-70-RB-RAABE
• Device Lot Number: 13155316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention