MAUDE Adverse Event Report: COOK INC SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	TSCF-35-180-3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.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 = dqx, pre-amendment.(b)().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
It was reported, a female patient in her "(b)(6)" 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); 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) this report; zisv6-35-125-7-100-ptx (3001845648-2018-00290).
Event or Problem Description
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional 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.

• Brand Name: SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7634314
• Report Number: 1820334-2018-01618
• Device Sequence Number: 2482258
• Product Code: DQX
• UDI-Device Identifier: 00827002009028
• UDI-Public: (01)00827002009028(17)230508(10)8789151
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2023
• Device Catalogue Number: TSCF-35-180-3
• Device Lot Number: 8789151
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening