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

Model Number	G07856
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: lead tech.Pma/510(k) number: pre-amendment.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a procedure to place a nephrostomy drain, a flexor introducer sheath hub separated from the sheath upon removal of the device, which had been in place for five minutes.The sheath was placed in the kidney and an unknown 0.035 inch wire was in the lumen of the sheath at the time of hub separation, at which point the wire came out of the sheath.The patient's anatomy was reportedly scarred; however, resistance was not reported.The dilator was not reinserted prior to removal of the device, which was pulled from the patient by the hub.The patient did not experience any blood loss, as the sheath was in the kidney instead of the vascular system.The nephrostomy drain was successfully placed in the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation.Reviews of the complaint history, device history record, drawing, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and dimensional verification of the returned device were conducted during the investigation.One flexor introducer sheath was returned for investigation.Visual inspection showed separation of the hub.Biomatter was present.No damage was noted to the shaft of the device.A slight thread mark was present on the proximal flare.The sheath flare was within dimensional specification.Additionally, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.A review of complaint history showed no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.The device is packaged with instructions for use, which warn, "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." the ifu further advises, ¿avoid applying traction to the hub.¿ the device was reportedly removed from the patient by pulling the sheath at the hub.Based on the information provided and the examination of the returned product, investigation has concluded that the device failure is likely attributable to the patient¿s scarred anatomy and the traction applied to the hub of the device during removal.We will continue our monitoring of similar complaints and have 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.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, during a procedure to place a nephrostomy drain, a flexor introducer sheath hub separated from the sheath upon removal of the device, which had been in place for five minutes.The sheath was placed in the kidney and an unknown 0.035 inch wire was in the lumen of the sheath at the time of hub separation, at which point the wire came out of the sheath.The patient's anatomy was reportedly scarred; however, resistance was not reported.The dilator was not reinserted prior to removal of the device, which was pulled from the patient by the hub.The patient did not experience any blood loss, as the sheath was in the kidney instead of the vascular system.The nephrostomy drain was successfully placed in the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Corrected information: g5: 510(k)= k142829.Investigation - evaluation: reviews of the complaint history, device history record, drawing, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and dimensional verification of the returned device were conducted during the investigation.One flexor introducer sheath was returned for investigation.Visual inspection showed separation of the hub.Biomatter was present.No damage was noted to the shaft of the device.A slight thread mark was present on the proximal flare.The sheath flare was within dimensional specification.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.A review of complaint history showed no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.There is thus evidence to support that the device was manufactured to specification and items in the same lot or similar devices in the field or in house are built to specification.The device is packaged with instructions for use, which warn, "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." the ifu further advises, ¿avoid applying traction to the hub.¿ the device was reportedly removed from the patient by pulling the sheath at the hub.Based on the information provided and the examination of the returned product, investigation has concluded that the device failure is likely attributable to the patient¿s scarred anatomy and the traction applied to the hub of the device during removal.We will continue our monitoring of similar complaints and have 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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9310929
• Report Number: 1820334-2019-02844
• Device Sequence Number: 14080835
• Product Code: DYB
• UDI-Device Identifier: 00827002078567
• UDI-Public: (01)00827002078567(17)220801(10)9920937
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2020

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: 08/01/2022
• Device Model Number: G07856
• Device Catalogue Number: KCFW-8.0-38-RB
• Device Lot Number: 9920937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 01/23/2020; 03/06/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/29/2020; 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1