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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: rt.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 an angiogram, atherectomy and angioplasty of the popliteal artery a flexor balkin guiding sheath was in use when it uncoiled from "the inside out".The user had advanced a balloon catheter through the sheath when they felt a "strange" resistance.The balloon and sheath were then removed, but as the sheath was removed it uncoiled.It is unknown how the procedure was completed.No portion of the device was left inside the patient.No additional procedures or prolonged hospitalization was required.The patient did not experience any adverse effects due to this occurrence.Additional information has been requested.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during an angiogram, atherectomy and angioplasty of the popliteal artery a flexor balkin guiding sheath was in use when it uncoiled from "the inside out".The user had advanced a balloon catheter through the sheath when they felt a "strange" resistance.The balloon and sheath were then removed, but as the sheath was removed it uncoiled.It is unknown how the procedure was completed.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.One 6fr kcfw sheath was received used, with biomatter present.The sheath was kinked at 5.5 cm with approx.14.2cm of exposed coil.Sheath measured 40cm.Radiopaque marker band was present.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a capa was previously initiated regarding this failure mode.The process of assembling the sheath was successfully validated for tensile strength; the minimum load required for failure (separation) was greater than 15 n.The capa team did not arrive at a definitive root cause and was closed at the end of the root cause phase.The following primary contributing factors have been identified: a.) these devices can be advanced into restrictive anatomies.The capa investigation showed that clinical users may be using these devices to force through restrictive anatomy, causing separation upon removal.B.) instructions for use warn to reinsert the dilator prior to removal.Investigation has identified that this is not always performed inspection activities are in place to prevent the release of non-conforming product related to the reported failure mode.No corrective actions will be pursued as the root cause investigation has identified that the product conforms to all design requirements and the incident rate is within the identified acceptable risk level.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.The investigation conclusion could not establish a definitive cause, but a potential cause can be attributed to the patents anatomy as the reported procedure (angiogram, atherectomy and angioplasty) can involve calcified anatomy.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.

• Brand Name: FLEXOR BALKIN GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10561063
• Report Number: 1820334-2020-01717
• Device Sequence Number: 13764582
• Product Code: DYB
• UDI-Device Identifier: 00827002322240
• UDI-Public: (01)00827002322240(17)230618(10)13254609
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 06/18/2023
• Device Model Number: N/A
• Device Catalogue Number: KCFW-6.0-38-40-RB-BLKN-HC
• Device Lot Number: 13254609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK MPIS WIRES; COOK PTA CATHETERS; COOK MPIS WIRES; COOK PTA CATHETERS
• Patient Age: 70 YR