MAUDE Adverse Event Report: ST. JUDE MEDICAL MAXIMUM HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number 406253

Device Problems Fracture (1260); Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Two maximum hemostasis introducers were used for a procedure.The sheath of one of the introducers broke during the procedure and a fragment of the introducer was surgically removed.A third maximum hemostasis introducer was opened for the procedure but was not used because a perforation was noted on the introducer.The reported adverse event (surgical intervention) was attributed only to the first introducer sheath fracture.

Manufacturer Narrative

Six introducers were opened and/or used during the case, whereas five were originally mentioned.(b)(4).Product investigation: the results of the investigation concluded that the sheath tubing had been stretched/torn and separated approximately 1.41¿ distal to the sheath hub.The detached tubing was 3.40¿ in length; the attached tubing distal end appearance had similar damage, consistent with a mating surface to the aforementioned detached tubing.The detached tubing had been kinked 1.9¿ from the distal tip.The sheath distal tip had been gouged, stretched, and flared on one side.There was no evidence found to suggest the incident was due to an intrinsic defect in the returned device.The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record.The cause of the sheath damage is consistent with forcible contact during use.The maximum hemostasis introducer ifu directs the user to advance the dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.The maximum hemostasis introducer ifu directs the user to inspect the sheath introducer and accessories for damage and directs the user not to use any damaged devices.

Event Description

Six maximum hemostasis introducers were opened for a procedure.The sheath of one of the introducers broke during the procedure and a fragment of the introducer was surgically removed from the patient.The sheath of another used introducer became kinked during use.Another of the maximum hemostasis introducers was opened for the procedure, but was not used because a perforation was noted on the introducer.The remaining three introducers were suspected to have similar perforations.

• Brand Name: MAXIMUM HEMOSTASIS INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 5960515
• MDR Text Key: 55059917
• Report Number: 2182269-2016-00020
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K870374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2016

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: 04/30/2019
• Device Model Number: 406253
• Device Catalogue Number: 406253
• Device Lot Number: 5520076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention