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

Model Number G44154

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant products: sphere inflation device, flexor introducer sheath, flexor ansel guiding sheath, micropuncture transitionless access set, advance 35 lp low profile balloon catheter, safe-t-j rosen catheter exchange wire guide, safe-t-j exchange fixed core wire guide, approach hydro st microwire wire guide.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, a female patient in her "early 60's" with a non-healing, left foot, vascular ulcer, underwent a stent placement (site not specified) on (b)(6) 2018 in an outpatient facility.Multiple cook products were used.On (b)(6) 2018, the patient presented to the emergency room with a fever (temperature unknown to complainant) and was admitted to the hospital.The patient was diagnosed with sepsis which was treated with "fluids and iv antibiotics" and is "doing fine".Reportedly, lab results indicate a strain of strep was identified, however, no further information has been provided.Per the complainant: "several cook products were involved with original procedure, unknown and not alleged at this time if any of them may have contributed to this." additional information regarding event details, patient anatomy and relevant medical history has been requested, but is not available at this time.Please reference additional medwatch numbers regarding all cook products in use during the procedure: cid-20-30-ng (1820334-2018-01470), kcfw-5.0-38-rb (1820334-2018-01613.), kcfw-6.0-18/38-45-rb-anl0-hc (1820334-2018-01614) this report, mpis-402-nt-u-sst (1820334-2018-01615), pta5-35-135-6-6.0 (1820334-2018-01616), thscf-35-180-1.5-rosen (1820334-2018-01617), tscf-35-180-3 (1820334-2018-01618), zisv6-35-125-7-100-ptx (3001845648-2018-00290).

Event Description

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

Manufacturer Narrative

Additional information was received from the customer.Regarding the patient's reported infection, the hospitalist ordered cultures after administering antibiotics.The chart note said "it presented like a streptococcal infection," but the organism was not able to be cultured for unspecified reasons.The customer confirmed that the streptococcal - like infection was the only reported symptom; no sepsis occurred as was previously reported.Investigation ¿ evaluation a review of the device history record and documentation of the device was conducted during the evaluation.The complaint device 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.There was no report of any product malfunction which could have caused or contributed to the patient¿s reported adverse event.We will continue to monitor for similar complaints.Per the 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.

Manufacturer Narrative

Correction: g5.This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.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 ANSEL GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7634209
• MDR Text Key: 112191180
• Report Number: 1820334-2018-01614
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002441545
• UDI-Public: (01)00827002441545(17)210406(10)8755413
• Combination Product (y/n): N
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2021
• Device Model Number: G44154
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 8755413
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Life Threatening