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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREX; THROMBECTOMY & ATHERECTOMY
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STRAUB MEDICAL AG ROTAREX; THROMBECTOMY & ATHERECTOMY Back to Search Results
Catalog Number 80202
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2024
Event Type  malfunction  
Event Description
It was reported that during a recanalization procedure, the middle and distal part of guidewire was allegedly broken.Reportedly, the patient underwent balloon retrieval for the broken guidewire and tabbing the stent at the lesion for distal part of the guidewire.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos and images were provided for review.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the catheter and guidewire were returned for evaluation and physically investigated.During physical investigation the guidewire was broken at 76.5 cm from the tip of it.Therefore, the investigation is confirmed for the reported guidewire break.A clear root cause could not be identified but a damaged guidewire represents a known inherent risk.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that during a recanalization procedure, the middle and distal part of guidewire was allegedly broken.Reportedly, the patient underwent balloon retrieval for the broken guidewire and tabbing the stent at the lesion for distal part of the guidewire.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the catheter and guidewire were returned for evaluation and physically investigated.During physical investigation, the guidewire was broken at 76.5 cm from the tip of it.Review of the customer provided pictures also shown broken guidewire.Therefore, the investigation is confirmed for the reported guidewire break issue.A clear root cause could not be identified but a damaged guidewire represents a known inherent risk.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.
 
Event Description
It was reported that during a thrombectomy and atherectomy procedure, the middle and distal part of guidewire was allegedly broken.Reportedly, the patient underwent balloon retrieval for the broken guidewire and tapping the stent at the lesion for distal part of the guidewire.There was no reported patient injury.
 
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Brand Name
ROTAREX
Type of Device
THROMBECTOMY & ATHERECTOMY
Manufacturer (Section D)
STRAUB MEDICAL AG
straubstrasse 12
ch-7323
wangs SG 73 23
SZ  SG 7323
Manufacturer (Section G)
STRAUB MEDICAL AG
straubstrasse 12
ch-7323
wangs SG 73 23
SZ   SG 7323
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key18709429
MDR Text Key336295117
Report Number3008439199-2024-00017
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K211738
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number80202
Device Lot Number231405
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/27/2024
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 Number1
Patient Age50 YR
Patient SexMale
Patient Weight46 KG
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