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

Catalog Number KCFW-6.0-35-70-RB-HFANL1-HC

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

Patient Problem Reaction (2414)

Event Date 07/24/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) number = pre-amendment this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

A report was received regarding a female patient who experienced a suspected allergic reaction after introduction of a cook flexor high-flex ansel guiding sheath during a pulmonary angioplasty procedure via the right femoral vein on (b)(6) 2018.The procedure occurred outside the united states.It was reported, upon introduction of the cook flexor high-flex ansel guiding sheath, the patient experienced a rapid heart rate (tachycardia), a sensation of tightness in the chest, transient elevation in pulmonary artery pressure (pap), "moderate desaturation" and a flushed (erythematous) reaction of the face.The symptoms resolved rapidly without intervention within one minute of their occurrence.The procedure was completed without any further occurrence of symptoms.The patient¿s significant past medical history includes: bilateral electrophysiology (ep) in (b)(6) 2017 complicated with post embolic pulmonary hypertension and treated with oxygen and antivitamins k (avk).Currently admitted to a respiratory rehabilitation program.Allergies include iron contact, electrodes, and some dressings.Current medications: previscan 15 mg/d, adempas 2.5 mg x 3/d, pantoprazole 20 mg, gaviscon, nicopatch.Note: mg (milligrams).The patient reported four sessions of pulmonary angioplasty for the right and left lower lobe of the lungs in (b)(6) 2018.Subsequently, the patient was weaned from oxygen but remained dyspneic with a new york heart association (nyha) 2 designation.The patient reported a similar reaction during the third pulmonary angioplasty procedure which was considered an anxiety attack.The patient is scheduled for one additional pulmonary angioplasty procedure on (b)(6) 2018 but will be premedicated with an antihistamine and a change to the material used.This procedure was previously planned and is not a result of the event reported here.Although requested, no information has been received regarding other devices or medications in use during the procedure.The complaint device will not be returned to the manufacturer for investigation.

Manufacturer Narrative

Additional information: b5.Additional information was received from the customer.As part of the initial procedure, xylocaine medication was administered.No treatment or medication was administered as a result of the physiological and potentially allergic response of the patient.The sheath was used to complete the procedure and was not removed, and the patient's overall outcome was reportedly very good following the reported intervention.Investigation evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing 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.While the lot number of the device was not known, it was confirmed that the device belonged to one of three lots.A review of each of the device history records for these lots was conducted.The first lot (lot 8582403) shows no nonconforming events which could contribute to this failure mode; however, there was one other reported complaint for this lot number.The second lot (lot 8667640) shows two nonconforming events which could contribute to this failure mode; however, there were no other reported complaints for this lot number.The third lot (lot 8836004) shows one nonconforming event which could contribute to this failure mode; however, 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.Measures are being conducted to address this failure mode.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

Additional information regarding the patient and or event has been received since the previous medwatch report was sent.This information is detailed in section h10.

Event Description

Upon further review of the complaint it was determined that the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction.There is no reported product malfunction.Furthermore, the reported symptoms experienced by the patient did not require any medical or surgical intervention.

Manufacturer Narrative

Upon further review of the complaint it was determined that the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction.There is no reported product malfunction.Furthermore, the reported symptoms experienced by the patient did not require any medical or surgical intervention.H1: this event does not meet the criteria for a malfunction, serious injury, or death.This report includes information known at this time.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7767656
• MDR Text Key: 116565315
• Report Number: 1820334-2018-02320
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2021
• Device Catalogue Number: KCFW-6.0-35-70-RB-HFANL1-HC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 10/01/2018; 10/02/2019
• Supplement Dates FDA Received: 10/03/2018; 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other