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

Model Number G44154

Device Problems Break (1069); Unraveled Material (1664)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

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 a selective angiogram of the left leg, a flexor ansel guiding sheath unraveled and separated.Access was obtained in a uniquely calcified groin/right femoral artery.The left common and external iliac arteries were calcified, the vessels were very tortuous, and there was a 90% occluded lesion in the mid-left superficial femoral artery.The complaint device was advanced into the left common iliac artery, at which point it became stuck within calcification and was unable to be advanced or pulled back.An unspecified "ima" catheter was then placed through the sheath and the catheter and sheath were pulled back together over a wire guide.The sheath subsequently unraveled and the sheath tip became stuck at the right femoral access site.A vascular surgeon was consulted, and a surgical cut-down procedure was performed to remove the tip of the sheath.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Event summary: as reported, during a selective angiogram of the left leg, a flexor ansel guiding sheath unraveled and separated.Access was obtained in a uniquely calcified groin/right femoral artery.The left common and external iliac arteries were calcified, the vessels were very tortuous, and there was a 90% occluded lesion in the mid-left superficial femoral artery.The complaint device was advanced into the left common iliac artery, at which point it became stuck within calcification and was unable to be advanced or pulled back.An unspecified "ima" catheter was then placed through the sheath and the catheter and sheath were pulled back together over a wire guide.The sheath subsequently unraveled and the sheath tip became stuck at the right femoral access site.A vascular surgeon was consulted, and a surgical cut-down procedure was performed to remove the tip of the sheath.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.One flexor ansel guiding sheath was received in a used condition with an unspecified catheter.The shaft of the sheath was separated, and the outer material accordioned, resulting in inner coil and liner exposure.On the unspecified catheter, the inner coiling and liner of a different section of the sheath were attached, and the catheter exhibited damage and separation.A document-based investigation evaluation was performed.No related non-conformances were recorded.One additional complaint was reported for this product lot for an unrelated failure mode.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which warn, ¿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.¿ based on the available information, cook has concluded that a cause for this event could not be established.A capa has been previously opened to further investigate this failure mode and is ongoing.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14322376
• MDR Text Key: 291884205
• Report Number: 1820334-2022-00694
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002441545
• UDI-Public: (01)00827002441545(17)241021(10)14296970
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

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
• Device Operator: Health Professional
• Device Model Number: G44154
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 14296970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CATHETER 5FR IM CRV 100CM LG INNER LUM RADOPQ; CATHETER 6FR 145D PGTL CRV 110CM 6SH RADOPQ BRAID; GUIDEWIRE GLDWR 3CM 260CM AND .035IN VASC NTNL PU; GUIDEWIRE HTORQ SUPRA CORE 300CM STRT .035IN VASC; GUIDEWIRE INQWR 150CM 3MM RDS J CRV .035 VASC; INTRODUCER 5FR 50CM 11CM GRAY HUB SNPFT DIL; INTRODUCER SHEATH 7FR 35MM 23CM KINK RST CANNULA; INTRODUCER SHTH 6FR 50CM 11CM GRN HUB SNPFT DIL; KIT INTRO 4FR 21G 10CM, 7CM .018STF DIL NTNL GW; PACK SURG PROC SET UP ASLMC ASMC CDL; SHEATH 6FR .087IN 45CM .018-.038 IN ANLO CRV; WIRE GLDWR ADV 5CM 260CM ANG 25CM .035IN VASC; WIRE LUNDERQUIST 11CM 260CM STRT .035IN VASC
• Patient Outcome(s): Required Intervention