MAUDE Adverse Event Report: TERUMO CLINICAL SUPPLY CO., LTD. PROGREAT LAMDA; MICRO CATHETER SYSTEM

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Insufficient Information (4580)

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Establishment name: (b)(6) hospital.The actual device has been returned for evaluation.Visual inspection for the involved device, only zizai (hereinafter referred to as the involved device) was returned.When observing the appearance of the involved device, there was a perforation in one place.Appearance of the involved device revealed a perforation was observed at the point of 0.6cm from the distal tip.Perforation of the involved device revealed that there was a perforation at the point of 0.6 cm from the distal tip.When the perforation that occurred in the involved device was enlarged and observed, the perforation was accompanied by the elongation of the resin from the inside to the outside.In addition, there was a kink on the back of the perforation.Using the sample guide wires, the size of the perforation that occurred in the involved device was compared.As a result, the size of the perforation that occurred in the involved device was smaller than the outer diameter of the 0.016-inch guide wire and was close to the outer diameter of the 0.014-inch guide wire.Perforation at 0.6 cm from the distal tip revealed that the resin near the perforation stretched from the inside to the outside toward the distal tip.Perforation of the involved device, there was a kink on the back of the perforation.Comparison of perforation part: perforation of the involved device + 0.014-inch guide wire, the perforation that occurred in the involved device was close to the outer diameter of the 0.014- inch guide wire.Comparison of perforation part: perforation of the involved device + 0.016-inch guide wire, the perforation that occurred in the involved device was smaller than the outer diameter of the 0.016-inch guide wire.Simulation tests of the perforation that occurred in the involved device were performed by following methods: sample: zizai guide wire (radifocus guidewire m rh16188) stainless-steel metal rod (outer diameter: 0.35mm / 0.014 inch).Method [1]: bend and fix the part of about 2 cm from the distal tip of the sample.In that state, insert the combination guide wire into the sample.Result [1]: the combination guide wire was inserted into the sample, and even after the distal tip of the combination guide wire reached the kink part of the sample, it was pushed in.However, the combination guide wire did not perforate the sample.In method [1], the similar perforation reproducibility to the involved device was not observed, so the additional simulation test was performed by the following method.Method [2]: insert a stainless-steel metal rod (outer diameter 0.35 mm) into the sample used in method [1].Result [2]: a stainless-steel metal rod was inserted into the sample, and even after the tip of the metal rod reached the kink part of the sample, it was pushed in.As a result, the metal rod pierced the kink part of the sample and perforated.When the perforated part of the sample was enlarged and observed, the resin was stretched from the inside to the outside like the involved device, and the similar reproducibility to the involved device was confirmed.Simulation test method conducted.Bend and fix the part of about 2 cm from the distal tip of the sample.Method [1]: insert the combination guide wire.Method [2]: insert a stainless-steel metal rod.Result [1] of simulation test.When the combination guide wire was pushed into the sample, the sample and the combination guide wire bent and did not perforate.Result [2] of simulation test.When a stainless-steel metal rod was pushed into the sample, the metal rod pierced and perforated the kink part of the sample.Simulation test result [2] perforated part of simulation sample (front).Simulation test result [2] perforated part of simulation sample (side).The perforation of the simulation sample was accompanied by the elongation of the resin from the inside to the outside.There was a kink on the back of the perforation of the simulation sample.The similar reproducibility to the involved device was observed.Perforated part of involved device (upper: front / lower: side).The dimensions of the involved device were measured for the following purposes: inner and outer diameters: inspection of the possibility that perforation has occurred in the catheter due to the thinness of resin, etc.As a result, the inner and outer diameters of the distal and proximal part of the involved device were within our standard values, and no abnormality was found.In our manufacturing process manufacturing process, we perform visual inspections toward all zizai before assembling to the holder.Visual inspections and dimension measurements, etc.Are also performed for each manufacturing lot.The device history records of the lot 211101480 were reviewed, and no disorder that may cause the perforation of the involved device was found.As a result of observing the appearance of the involved device, there was a perforation in one place.When the perforation that occurred in the involved device was enlarged and observed, the perforation was accompanied by the elongation of the resin from the inside to the outside.In addition, there was a kink on the back of the perforation.Comparing the size of the perforation occurred in the involved device using the sample guidewire, the perforation that occurred in the involved device was close to the outer diameter of the 0.014-inch guidewire.When simulation tests were performed, even if the guidewire was inserted into a sample for which a kink was prepared, the similar reproducibility to the involved device was not observed.In addition, when a metal rod was inserted into the sample in which the kink was prepared, the similar perforation reproducibility to the involved device was confirmed.From the dimension measurement and inspection of manufacturing records, no abnormalities that could cause tip flattening, catheter perforation, and deformation such as kink or bending were observed.From the information you provided, all guide wires which were used with the involved device had an outer diameter of 0.014 inch.Based on these results, it was presumed that the perforation of the involved device may have been occurred by a load from the inside to the outside, such as pushing of the combination device in a state where there was resistance to passage, such as the kinking or bending of the catheter.(b)(4).

Event Description

The user facility reported that doctor tried to pass the involved device through the #9 cto lesion, however it would pass.When the combination guide wire (gaia next 3) was replaced with another combination guide wire (gaia next 4), the combination guide wire (gaia next 4) penetrated at the point of about 1cm from the distal tip of the involved device.

• Brand Name: PROGREAT LAMDA
• Type of Device: MICRO CATHETER SYSTEM
• Manufacturer (Section D): TERUMO CLINICAL SUPPLY CO., LTD.; 3 kawashima-takehaya-machi; kakamigahara,; gifu, 501-6 024,; JA 501-6024,
• Manufacturer (Section G): TERUMO CLINICAL SUPPLY CO., LTD.; reg. no. 3009500972; 3 kawashima-takehaya-machi; kakamigahara, gifu, 501-6 024; JA 501-6024
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 14788037
• MDR Text Key: 295425587
• Report Number: 3009500972-2022-00003
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: NC-C785AM
• Device Lot Number: 211101480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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