MAUDE Adverse Event Report: COOK INC PERFORMER MULLINS GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number G09210

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant products: lunderquist wire, wedge balloon catheter, mustang and atlas dilation balloons.Pma/510(k) number = pre-amendment.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, during a conduit dilation with stent placement procedure, the hub broke off the dilator of the performer mullins guiding sheath during removal.This occurred twice with this same lot number.Both times the dilators were retrieved from the patient's anatomy using snap forceps.According to the complainant, the patient experienced blood loss; however, no additional procedures were required.No additional adverse effects were reported.A section of the device did not remain inside the patient¿s body.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Previously requested additional information was later received from the customer.It was confirmed that the location of the incident was safra children's hospital in tel hashomer, israel.Additionally, the separation of the device which was reported occurred upon the removal of the dilator.The customer confirmed that nothing was inserted into the lumen of the sheath prior to removal.The patient reportedly had calcified homografts, but the sheath was reportedly not yet in the homograft when the separation occurred.The procedure was confirmed to be a homograft dilation with stent, and the access site was reportedly the "rfv" [sic].A lunderquist wire was used in conjunction with the complaint device.To complete the procedure, the dilator was removed using a clamp, and a long sheath was advanced into the homograft, at which point it was "stunted and post-dilated" [sic].The patient's overall outcome was good, and there was only one patient involved.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 Description

Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.This information is detailed.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information : it was initially reported that the device was going to be returned for evaluation.However, the device was not returned.This field has been updated to 'not returned to manufacturer'.Investigation evaluation: a review of the complaint history, device history record, manufacture instructions, and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Additionally, because these devices were not returned, the device failure analysis from (b)(4).Is referenced for the same failure of a similar device.(b)(4).Device failure analysis reads ¿the hub was separated from the shaft of the dilator.The dilator was cut during previous physical examination.The sheath was not returned.The flare of the dilator is slanted approximately 5 degrees, which is considered out of specification per qsi04_13.There are thread marks on the outside of the tubing at the flare, indicating the tubing was caught in the flare.The flared tubing was reassembled with the cap and adapter.Upon assembly, the tubing pulled through the opening of the cap easily." the device for (b)(4).Was confirmed to be out of specification upon evaluation, however because they were not returned, we are unable to confirm that the devices for (b)(4).Were not built to specification.There are no related nonconformances and no additional complaints on lot 7432010.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.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 Description

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

• Brand Name: PERFORMER MULLINS GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7616053
• MDR Text Key: 111567850
• Report Number: 1820334-2018-01700
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002092105
• UDI-Public: (01)00827002092105(17)191109(10)7432010
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2019
• Device Model Number: G09210
• Device Catalogue Number: RCFW-14.0-38-75-RB-MTS
• Device Lot Number: 7432010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 YR