MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 CERE 6MMX26CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number PC410062630

Device Problems Break (1069); Kinked (1339); Stretched (1601)

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

Event Date 03/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This initial/final mdr will be the only report submitted for this mfr report.Additional patient information has been requested, but a response has not yet been received.The lot number is unknown, therefore the device manufacture and expiration dates are unknown.(b)(6).Additional initial reporter contact information has been requested, but a response has not yet been received.(b)(4).Conclusion: the device was returned for analysis and the distal end of the embolic coil is located in the translucent introducer sheath.The embolic coil is protruding through the skive of the translucent introducer sheath, where it is stretched and separated.The proximal end of the embolic coil is detached from the device positioning unit (dpu).The dpu is removed from the translucent introducer sheath.The detached piece of embolic coil and the distal end of the dpu are tangled with the proximal end of the translucent introducer sheath (proximal to the resheathing tool).The detached embolic coil is stretched.There are bends in the dpu core wire approximately 105 cm and 141 cm from the proximal end.The ball tip of the embolic coil section enclosed in the translucent introducer sheath is intact.The section of embolic coil that is enclosed in the translucent introducer sheath is kinked.The embolic coil is kinked at the point where it protrudes from the skive of the translucent introducer sheath.The protruded embolic coil is stretched.The v-notch of the resheathing tool is undamaged.The embolic coil is severely stretched.The embolic coil that is involved in the tangle includes a ball tip, and is therefore a separate embolic coil from the one found in the translucent introducer sheath.Two proximal solder rings were located in the tangle.A separated end of embolic coil could not be located in the tangle.The resistance heating (rh) coil has not heated.Advancement cannot be tested because of the severe damage to the device.The lot number of the device is unknown.Without the lot number, a device history record (dhr) review cannot be completed.The complaint that the device is impeded in the microcatheter cannot be confirmed.There is severe damage to the device, and advancement cannot be tested.There are apparently 2 embolic coils in the return package.The distal end of one embolic coil is located in the translucent introducer sheath.This segment is a distal segment and includes an intact ball tip.The proximal end of this segment protrudes from the skive of the translucent introducer sheath, where it is stretched and separated.Within the translucent introducer sheath, this segment of embolic coil is kinked in several locations.There is a tangle of embolic coil, dpu, and introducer.The tangle includes the ball tip of and embolic coil and two solder rings, suggesting that there is one full embolic coil and the proximal end of an embolic coil included in the tangle.The separated distal end of a partial embolic coil could not be located, but is presumably present because of the presence of two solder rings.The cause of the kinks in the section of embolic coil enclosed in the introducer cannot be identified.However, 100% of devices are inspected during final assembly by advancing the embolic coil out of the introducer, inspecting the embolic coil, and retracting back into the introducer.Damage as severe as that observed would prevent the embolic coil from advancing or retracting.Thus, it is unlikely that the device left the manufacturing facility with the observed kinks in the embolic coil.While the circumstances surrounding the reported event are unknown, it is possible that the resheathing tool was advanced over the embolic coil while unsheathing the device.The ifu instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing the embolic coil into the microcatheter, there is a risk that the embolic coil will be unsheathed and pass through the resheathing tool.This can cause damage to the embolic coil and can also cause it to protrude from the introducer.Once the embolic coil has protruded from the skive of the translucent introducer sheath, it cannot be advanced or retracted.Application of excessive retraction force will cause the embolic coil to stretch.Since the rh coil has not heated, the embolic coil was most likely detached mechanically.This is consistent with the stretched and tangled condition of the returned device.The circumstances surrounding the formation of the tangle of embolic coil, dpu, and introducer, as well as the source of the second embolic coil, are unknown.However, it is likely that the tangle was formed after the device was removed from use, and could have occurred while the device was being processed for storage and/or return.

Event Description

It was reported by a healthcare professional that a presidio 10 coil ((b)(4)/unknown lot) was used as the first or second coil during a procedure when the coil could not be advance or retrieved by the physician.Note: several attempts have been made for additional information, but a response has not been received to date.If additional information becomes available, it will be forwarded within 30 days of receipt.This complaint was deemed mdr reportable as a result of device evaluation results.

• Brand Name: PRESIDIO 10 CERE 6MMX26CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF INC.; 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; chemin-blanc 38; le locle neuchatel CH-24-00 ; SZ CH-2400 ; 949789-868
• MDR Report Key: 7573706
• MDR Text Key: 110706111
• Report Number: 3008114965-2018-00644
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528003021
• UDI-Public: 00878528003021
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PC410062630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• 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