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

Model Number G09210

Device Problem Kinked (1339)

Patient Problem No Code Available (3191)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

Per the initial reporter, the device will not be returned.Pma/510(k) number = preamendment.(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 that during an angioplasty, the 14 fr performer mullins guiding sheath was used to introduce an 8 fr balloon valve and to place a stent; introduction of the balloon occurred without issues.The patient's lesion was located in the pulmonary artery and the course was tortuous.The physician was able to advance the balloon, but was unable to remove the balloon from the sheath after dilation of the artery, and had to remove the entire system from the patient's anatomy.The sheath was observed to have several folds that prevented the angioplasty from being completed.As a result of the sheath folds/ kinking, the physician was required to re-schedule the stent implantation.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information regarding event details and patient anatomy has been requested, but is not available at this time.

Manufacturer Narrative

Photographs of the complaint device which were received were also evaluated as part of the investigation of the device.The photo provided by the customer showed that the blue sheath tubing of the device had kinked in several places.The findings of the investigation were not changed.

Event Description

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

Manufacturer Narrative

Additional information was received from the customer.It was confirmed that the device being used through the sheath was a "stent cp" [sic].The sheath was placed in the patient's leg (femoral placement), and access was achieved through a contralateral approach.The several kinks which were reported occurred when the user was navigating the device through the patient; however, it was confirmed that separation did not occur prior to placement on the patient.The patient's anatomy was confirmed to be tortuous.Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device itself was not returned; therefore, no physical examinations could be performed.However, 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 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.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.

• 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: 7381464
• MDR Text Key: 103818685
• Report Number: 1820334-2018-00775
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002092105
• UDI-Public: (01)00827002092105(17)200322(10)7770964
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G09210
• Device Catalogue Number: RCFW-14.0-38-75-RB-MTS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR