MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA GLIDESHEATH; INTRODUCER, CATHETER

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/21/2022

Event Type  Injury  

Event Description

The user facility reported that after ablation using a 6 fr and 8.5 fr sheath, the involved radiofocus introducer device was removed.The device was fractured, and a fragment (about 6 cm) was left in the patient.The doctor stated that there was no resistance during the manipulation of removal.The fragment was retrieved successfully with a snare through an 11 fr sheath and the procedure was completed.The patient recovered from minor harm.The event occurred intra-operative.

Manufacturer Narrative

Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.Udi - n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k): k062858, k082644.Visual inspection of the actual sample found that the sheath tube had been fractured and divided into the distal portion and the main body.The length was confirmed to be about 90 mm and 10 mm respectively.Since the length of a normal product is about 100 mm, it was likely that no portion was missing from the actual sample.Magnifying inspection of the fractured area found an elongation in the distal portion.In the main body, an elongation and a scratch near the elongation were observed.Magnifying inspection of the other areas found a dent at about 27 mm from the distal end, and from this point over about 30 mm had been crushed.From the description of the event, the dent was caused when the distal portion was retrieved with a snare from the patient.The fractured area was inspected with an electron microscope, and the following was found in both the distal portion and the main body.Some part was shaped like stretched and torn-off.The fracture surface was smooth.From the above, it was inferred that a sharp object came into contact with the sheath, causing a scratch, which was subsequently subjected to tensile load and fractured starting from the scratch.Assuming that the sheath was exposed to a sharp object and then to tensile force, the following simulation tests have been conducted in the past.After the sheath was scratched using a scalpel, a tensile load was applied until the sheath tube was fractured.As a result, the followings were observed; i) the sheath was partially stretched and torn-off, ii) the fracture surface was smooth.These conditions were considered similar to those of the actual sample.Since the lot number of the actual sample was unknown, review of the manufacturing history or the complaint record could not be performed.From the investigation results, it was inferred that a sharp object came into contact with the sheath, causing a scratch, which was subsequently subjected to tensile load and fractured starting from the scratch.However, from the condition of the actual sample, the object that might have come into contact with the sheath could not be clarified.Relevant ifu reference: "do not scratch the sheath with needle point, cutting tool, or other edged tools." terumo medical products (tmp) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide a correction to section b2.

• Brand Name: GLIDESHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15266884
• MDR Text Key: 298323911
• Report Number: 9681834-2022-00163
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RR-A50K10A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: RR-A60K25AK; RR-A72K30AL
• Patient Outcome(s): Required Intervention; Other