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Catalog Number ZE-8-100P
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2019
Event Type  Injury  
Manufacturer Narrative
Since the actual device was not retuned, we investigated the device history records. The device history records (dhr) of the device concerned was reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections including the visual test, shaft pressurized test and the balloon-wrapping test for every product, and the finished product inspections including the shaft tensile strength test and the repetitive balloon inflation/deflation test on representative samples based on sampling plan. No nonconformity or abnormality in the manufacturing processes of the device concerned was found. Probable cause(s) and our comment: it is inferred that the portion of the balloon fell off by pulling the catheter forcibly after the portion of the balloon was trapped in the calcified lesion.
Event Description
The concerned device subject to this reported event, "ikazuchi zero", an rx-type ptca balloon catheter compatible with 0. 014" guidewire (gw), is no distributed in the us, however, we intend to report this case as the event occurred on one of the similar devices for "rx takeru ptca balloon dilatation catheter" distributed in the us under 510(k) # k163372. As reported by the sales rep: the patient woman around (b)(6) old. Second procedure , elective pci. Rca proximal calcified moderately around 90%. Radial approach , radial sheath terumo 6f, wire sion black, dx jr4 5f, gc al075 6 f medtronic, first attempt with a ptca 2*15 yanktzi biotronik that did not pass the lesion than moved to 1*8 ze-8-100p sp108550, nurse opened the balloon handed to dr elias (second operator) , dipped the balloon in saline in the sheath smoothly on the same wire which passed the lesion smoothly, moved to the distal part of the lesion in the rca in this time the doctor notices blood coming back from indiflator decides to remove all and exchange the balloon when pulling out only half of the shaft is removed and half including the balloon remains in the body, the patient started to feel un comfort and showed frank signs of severe ischemia including chest pain, diaphoresis, shortness of breath and st segment elevation via monitor. The management of the situation required intravenous fluids, morphiom and midazolam. The doctor made an attempt to access the artery with tazzuna 1. 25*15 un successfully as the part of the ikazuchi was in the artery in an occluding position the guiding cath and wire jumped out. And the single radio pack marker of the ikazuchi was evident in the distal rca while the markers of the shaft were not seen in the frame. Then they changed the guiding catheter to jr4 6f cordis. Guide liner 6f technic was utilized ( vascular solutions ) with sion black and still could not pass the lesion as the artery was occluded by the distal rapid exchange portion of the balloon, the wire was changed to pilot 200 wire that passed eventually after a few tries to the true lumen of the rca, the patient required additional morphin and midazolam. Then guide liner was introduced and several balloons inflations where preformed for sufficient flow restoration which stopped the patient's pain ¿ tazzuna 2*15 3 stents where implanted ultimaster terumo 3 * 28 distal, 2. 5*28 mid, 3. 5*33 proximal. In order to jail the balloon in the rca. After achieving a good angiographic result in the rca and after the remission of symptoms in the patient. The dr opened another ikazuchi ze-8-120 to learn the balloon and understand which part is still in the body. Radiographic comprehend was conducted to learn the missing part in length and radiopacity. Radiographic scanning was performed for total arteries in the body to locate the missing portion of the balloon that was found proximal to the right cubital fossa (brachial artery) in to the subclavian, aorta, jailed in the stents until the radio pack tip in the distal rca (62 cm). The dr considered to send the patient to the or to remove the shaft surgically and decided to try and retrieve the shaft in an endovascular technic, the dr used the guide liner the wire and the balloon to improvise a gentile snare fearing to use the regular snare that might damage the brachial artery, after a few attempts the remaining shaft was ingulfed in the gc in the brachial artery region and trapped inside the gc with a balloon in high pressure and carefully retrieved all the system out of the patient body. During retrieval, the single radiopaque marker of the balloon was demonstrated passing through the brachial artery. The entire device was removed out of the body, no remaining parts in the patient. The patient is feeling good and is planned to be released today.
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Manufacturer (Section D)
osaka-city, osaka 530-8 288
JA 530-8288
Manufacturer Contact
yoshiyuki kitamura
osaka-city, osaka 530-8-288
JA   530-8288
MDR Report Key8779038
MDR Text Key150692264
Report Number3002808904-2019-00019
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2021
Device Catalogue NumberZE-8-100P
Device Lot NumberSP108550
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/10/2019 Patient Sequence Number: 1